Drug GMP Report Subscription

Drug GMP Report

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.

$1,045.00

Drug GMP Report Free Trial Subscription

Drug GMP Report gives you in-depth coverage of technical quality control issues that directly affect your drug development and production processes. Each monthly issue provides concise, easy-to-read explanations of key regulatory trends and advice to make FDA regulatory compliance easier. With Drug GMP Report you’ll be able to stay up to date on the latest inspection hot spots, developments in certification procedures, electronic data requirements, and evolving trends in drug GMP enforcement.

Monthly, 30-day electronic trial subscription

$0.00

Drug Industry Daily Subscription

Drug Industry Daily

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators ... and what their competitors are up to.

Don't waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID's experienced in-house editorial team do the work for you. Use your energy where it's needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

PLUS: in every issue, you get links to additional documents that support DID’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug Industry Daily, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug Industry Daily today. It couldn’t be easier.

$1,695.00

Drug Industry Daily Free Trial Subscription

This daily electronic briefing delivers coverage of what’s happening on Capitol Hill and at the FDA, FTC, HHS, NIH and other key agencies and decision-making bodies that affect the pharmaceutical industry. Each issue gives you hard reporting on top issues, such as drug-safety oversight, clinical trial registries, adverse event reporting and warning letters. Written by FDAnews’ veteran staff of reporters, you get the news as it happens with the added perspective that only seasoned reporters can provide. It’s the fastest, most reliable way to make sure you’re an industry expert.

Daily, 30-day electronic trial subscription

$0.00

The GMP Letter Subscription

The GMP Letter

The GMP Letter (GMP) to stay on top of the FDA's interpretation and enforcement of the quality systems regulation and to learn which changes they must make to stay in compliance. In each monthly issue, you get an update on key regulatory developments, tips on how to prepare for FDA inspections, proven ways to improve design control procedures, ideas to create more effective GMP training programs and more.

With a subscription to The GMP Letter, you’ll get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

Each issue provides:

  • New and draft FDA guidances;
  • Implications of new regulations
  • Reasons/causes for the most recent warning letters;
  • Updates on key regulatory developments;
  • Tips to prepare for FDA inspections;
  • Proven ways to improve design control procedures; and
  • Ideas to create more effective GMP training programs.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with The GMP Letter, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to The GMP Letter today. It couldn’t be easier.

$1,085.00

The GMP Letter Free Trial Subscription

Use The GMP Letter to stay on top of FDA’s interpretation and enforcement of the Quality System Regulation (QSR) – and know which changes your firm must make to comply. Each month, The GMP Letter provides an informed report of key regulatory developments, tips on what you can do to prepare for FDA inspections, proven ways to improve design control procedures and tips on creating more effective GMP training programs.

Monthly, 30-day electronic trial subscription

$0.00

International Medical Device Regulatory Monitor Free Trial Subscription

Every month you get a comprehensive briefing on the latest regulatory developments around the world, including the U.S., Europe, Latin America, Asia, Canada, Australia and more. Plus you get actual full, official English-language texts of important, hard-to-obtain proposals, regulations, rules, directives, guidances and other documents to keep you completely up-to-date on significant developments in medical device regulatory policies worldwide. Save hours on research time and overcome barriers to application approval.

Monthly, 30-day electronic trial subscription

$0.00

International Pharmaceutical Regulatory Monitor Subscription

International Pharmaceutical Regulatory Monitor

International Pharmaceutical Regulatory Monitor (IPRM) keeps pharma professionals on top of key changes in pharmaceutical regulation around the world, covering rules and standards from the FDA, the European Medicines Agency, Health Canada, Australia's TGA, the International Conference on Harmonisation and other agencies in Europe, Japan and elsewhere.

PLUS: in every issue, you get links to additional documents from international agencies and commissions that support IPRM’s articles, such as draft and final guidances, regulations and amendments, rules, court decisions, guidelines, procedures, explanatory notes and more.

With your subscription you’ll also receive:

  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
  • Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
  • FDAnews Drug Daily Bulletin. This daily email alert brings you important FDA and international regulatory, legislative and business news in the pharmaceutical industry.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with International Pharmaceutical Regulatory Monitor, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to International Pharmaceutical Regulatory Monitor today. It couldn’t be easier.

$895.00

International Pharmaceutical Regulatory Monitor Free Trial Subscription

Stay on top of key changes in pharmaceutical regulation around the world with this monthly resource for rules and standards flowing from the FDA, the European Agency for the Evaluation of Medicinal Products, Health Canada, Australia's TGA, the International Conference on Harmonization and other agencies in Europe, Japan and elsewhere. In addition to a comprehensive briefing, you get actual, full official English-language texts of important, hard-to-obtain proposals, regulations, rules, directives, guidances and other documents, to help you prepare better-documented, properly formatted drug applications for fastest processing.

Monthly, 30-day electronic trial subscription

$0.00

Drug GMP Report Subscription

Click here to subscribe now!

Stay in compliance, boost efficiency and ensure profitability with Drug GMP Report, the nation's leading independent source of FDA regulatory news and guidance. In a quick, easy-to-read format, you'll get the knowledge you need on good manufacturing practice (GMP) regulations, FDA enforcement trends, international regulations and more.

Subscribe today and get the latest on:

  • GMPs, up-to-date warning letters and responses to them
  • Details of new FDA inspection hot spots
  • Developments in certification procedures and electronic data requirements
  • And much more

Click here to read
a sample issue

Each monthly issue of Drug GMP Report provides concise, easy-to-read explanations of key regulatory trends and advice to make FDA regulatory compliance easier, along with in-depth coverage of technical quality control issues that directly affect your drug development and production processes.
 
Plus, Drug GMP Report is backed with a 100 percent money-back guarantee: If at any time you become dissatisfied, you may cancel your subscription and receive a refund of your subscription fee.

Note: For print delivery outside of North America, your credit card will be charged an additional $25 for shipping and handling. 

Click here to view the current issue of Drug GMP Report, you must be a subscriber to Drug GMP Report to read full articles.

One-year subscription, monthly, 12 issues

$939.00

Drug Industry Daily Subscription

Click here to subscribe now!

Get the latest news and information on FDA regulatory, legislative and business developments with Drug Industry Daily, the premier resource for pharmaceutical professionals whose jobs depend on knowing what Congress, the FDA and other key regulators will do next — and what your competitors are up to.

Each and every day, Drug Industry Daily is delivered to your email inbox. And within minutes, you’ll know where you need to spend your energy and your dollars to ensure your products are in compliance and make it to market.

Subscribe today and get the latest on:

  • Federal and state enforcement actions
  • Congressional investigations and proposed laws
  • Your competitors' pipeline progress
  • Major payers' policy changes affecting drug sales
  • Proposed and final regulatory changes
  • Court decisions affecting patents, mergers and marketing
  • And much more

Click here to read
a sample issue

Written by FDAnews' veteran staff of reporters, Drug Industry Daily gives you the news as it happens with the added perspective that only seasoned reporters can provide. It's the fastest, most reliable way to make sure you're an industry expert.

Plus, Drug Industry Daily is backed with a 100 percent money-back guarantee: If at any time you become dissatisfied, you may cancel your subscription and receive a refund of your subscription fee.

Click here to view the current issue of Drug Industry Daily.

You must be a subscriber to Drug Industry Daily to read full articles.

One-year subscription, daily, 250 issues

$1,895.00

International Medical Device Regulatory Monitor Subscription

Click here to subscribe now!

Stay current on significant medical device regulatory policies worldwide to ensure you can sell your products in the global marketplace with International Medical Device Regulatory Monitor. Every month, you get a comprehensive briefing on the latest regulatory developments around the world, including the U.S., Europe, Latin America, Asia, Canada, Australia and more.

Subscribe today and get the latest on:

  • Developing nations and opportunities in their markets
  • New and draft global regulations
  • How changes made to inspection procedures outside the U.S. will impact your operations
  • The steps being taken to improve device safety around the world
  • Technological challenges that could impact importation of devices
  • And much more

Click here to read
a sample issue

International Medical Device Regulatory Monitor is the fastest, easiest and most economical way to get full English-language texts of important, hard-to-obtain proposals, rules, directives, guidances and other regulatory documents worldwide.

Plus, International Medical Device Regulatory Monitor is backed with a 100 percent money-back guarantee: If at any time you become dissatisfied, you may cancel your subscription and receive a refund of your subscription fee.

Note: For print delivery outside of North America, your credit card will be charged an additional $75 for shipping and handling. 

Click here to view the current issue of International Medical Device Regulatory Monitor, you must be a subscriber to International Medical Device Regulatory Monitor to read full articles.

One-year subscription, monthly, 12 issues

$699.00

International Pharmaceutical Regulatory Monitor Subscription

Click here to subscribe now!

Keep up to date on significant pharmaceutical regulatory policies worldwide to ensure you can test, manufacture and sell your products in the global marketplace with the International Pharmaceutical Regulatory Monitor. Each comprehensive briefing provides the latest regulatory developments around the world, including rules and standards flowing from the FDA, the European Medicines Agency, Health Canada, Australia’s Therapeutic Goods Administration, the International Conference on Harmonisation and other agencies in Europe, Japan and more.

Subscribe today and get the latest on:

  • Developing nations and opportunities in their markets
  • New and draft global regulations
  • How changes made to inspection procedures outside the U.S. will impact your operations
  • Proposals to improve drug safety around the world
  • The FDA (and other agencies’) increased focus on risk management
  • And much more

Click here to read
a sample issue

International Pharmaceutical Regulatory Monitor is the fastest, easiest and most economical way to get full English-language texts of important, hard-to-obtain proposals, rules, directives, guidances and other regulatory documents worldwide.

Plus, International Pharmaceutical Regulatory Monitor is backed with a 100 percent money-back guarantee: If at any time you become dissatisfied, you may cancel your subscription and receive a refund of your subscription fee.

Note: For print delivery outside of North America, your credit card will be charged an additional $75 for shipping and handling. 

Click here to view the current issue of International Pharmaceutical Regulatory Monitor, you must be a subscriber to International Pharmaceutical Regulatory Monitor to read full articles.

One-year subscription, monthly, 12 issues

$695.00

The GMP Letter Subscription

Click here to subscribe now!

Improve quality, work more effectively with the FDA and other regulators, and create better good manufacturing practice (GMP) training programs with The GMP Letter. Delivered monthly, each issue is packed with a thorough analysis of warning letters, response letters and new regulations to keep your operations in compliance with the FDA.

Subscribe today and get the latest on:

  • New and draft FDA guidances
  • Implications of new regulations
  • What prompted the most recent warning letters
  • Ways to improve design control procedures
  • And much more

Click here to read
a sample issue

Each issue of The GMP Letter provides in-depth analysis of new legislation, developing news stories and how changes to FDA regulatory policies may affect you. It’s the news you need to stay in compliance, boost efficiency and remain profitable.

Plus, The GMP Letter is backed with a 100 percent money-back guarantee: If at any time you become dissatisfied, you may cancel your subscription and receive a refund of your subscription fee.

Note: For print delivery outside of North America, your credit card will be charged an additional $25 for shipping and handling. 

Click here to view the current issue of The GMP Letter, you must be a subscriber to The GMP Letter to read the full articles.

One-year subscription, monthly, 12 issues

$895.00

International Medical Device Regulatory Monitor Subscription - Electronic Delivery

Special Offer for MDMA Members! Save $50 on your subscription!

Click here to subscribe now!

Stay current on significant medical device regulatory policies worldwide to ensure you can sell your products in the global marketplace with International Medical Device Regulatory Monitor. Every month, you get a comprehensive briefing on the latest regulatory developments around the world, including the U.S., Europe, Latin America, Asia, Canada, Australia and more.

Subscribe today and get the latest on:

  • Developing nations and opportunities in their markets
  • New and draft global regulations
  • How changes made to inspection procedures outside the U.S. will impact your operations
  • The steps being taken to improve device safety around the world
  • Technological challenges that could impact importation of devices
  • And much more. Plus, as an MDMA member, you save $50 on your subscription!

Click here to read
a sample issue

International Medical Device Regulatory Monitor is the fastest, easiest and most economical way to get full English-language texts of important, hard-to-obtain proposals, rules, directives, guidances and other regulatory documents worldwide.

Plus, International Medical Device Regulatory Monitor is backed with a 100 percent money-back guarantee: If at any time you are unsatisfied with International Medical Device Regulatory Monitor, you may cancel your subscription and receive a refund of your subscription fee.

One-year subscription, monthly, 12 issues

* $50 discount applies to new subscriptions only. 

$649.00

The GMP Letter Subscription - Electronic Delivery

Special Offer for MDMA Members! Save $100 on your subscription!

Click here to subscribe now!

Improve quality, work more effectively with the FDA and other regulators, and create better good manufacturing practice (GMP) training programs with The GMP Letter. Delivered monthly, each issue is packed with a thorough analysis of warning letters, response letters and new regulations to keep your operations in compliance with the FDA.

Subscribe today and get the latest on:

  • New and draft FDA guidances
  • Implications of new regulations
  • What prompted the most recent warning letters
  • Ways to improve design control procedures
  • And much more. Plus, as an MDMA member, you save $150 on your subscription!

Click here to read
a sample issue

Each issue of The GMP Letter provides in-depth analysis of new legislation, developing news stories and how changes to FDA regulatory policies may affect you. It’s the news you need to stay in compliance, boost efficiency and remain profitable.

Plus, The GMP Letter is backed with a 100 percent money-back guarantee: If at any time you are unsatisfied with The GMP Letter, you may cancel your subscription and receive a refund of your subscription fee.

One-year subscription, monthly, 12 issues

*$100 discount applies to new subscriptions only. 

$795.00

483sOnline.com - One-Year Unlimited Access Subscription

It’s no secret: Form 483s are the best resources available to understand what FDA investigators are looking for today. In fact, by referring to the observations in recently-issued 483s, you can:

  • Prepare your own facility to withstand the inspection scrutiny;
  • Assess your competitors’ compliance;
  • Background potential business partners’ compliance records;
  • Learn from the mistakes of others and better manage your own manufacturing operations; and
  • Create training and quality improvement scenarios based on real-life findings.

There’s only one catch about 483s. It isn’t very easy or cost-effective to get them from the FDA. First, there’s the expense of using staff time to make your FOIA request … then the cost of each 483 … and finally the long wait before they actually arrive.

But now there’s a new, better way to acquire 483s.

With a subscription to 483sOnline.com, you get round-the-clock, unlimited access to more than two thousand recent 483s ... with new ones being added weekly. Need to find what you are looking for in a hurry? You can search by:

  • Company name
  • Date of Inspection
  • Inspector Name
  • Region
  • Keyword

And the 483s are ready for you to download instantly.

You even get a weekly email notice of the new 483s we've added, so you're sure never to miss a thing.

This subscription is for single user only. Licenses for multiple users and/or multiple locations are also available at significant discounts. For more information, contact Nelly Valentin at nvalentin@fdanews.com or (888) 838-5578.

$997.00

PharmaSupplyChain.com - One-Year Membership Subscription

Order Online TodayPharmaSupplyChain.com from FDAnewsis a 24/7 broad-based information service for senior executives at every point in the pharmaceutical supply chain. Hard data. Quality standards. Breaking news. In-depth analyses. Best practices. Lessons learned from supply chain experts and colleagues who face the same sort of challenges you face. Make this website your one-stop shop for expert advice and guidance on developing supplier quality agreements ... auditing suppliers ... conducting due diligence on contract manufacturing organizations ... and much more.

PharmaSupplyChain.com offers information in a variety of formats. In addition to written articles, you’ll find slide presentations, plus audio and video from webinars and onsite conferences.

Your membership to PharmaSupplyChain.com by FDAnews, entitles you to access a vault of information you'll rely on again and again in your day-to-day duties: official inspection reports, warning letters, recalls, import alerts, consent decrees, court rulings, regulations, laws, guidances and guidelines from the U.S. FDA, EU, MHRA and many other regulatory bodies on quality requirements. This information vault includes reports from lawmakers, think tanks and researchers parsing the latest on drug shortages, counterfeit and fake drugs, and many more supply chain issues that affect the way you do business.

Every week, you'll receive an email listing the latest additions to the website, including exclusive news reports, how-to articles, new rules, regulations, government reports and stakeholder research to keep you on the leading edge of current trends impacting the pharma supply chain.

Just look at what you'll get:

  • 100-plus news articles from 2011 and 2012, with new articles added each week
  • 20-plus regulations, guidances and guidelines on GMP and supplier issues from the U.S., EU, U.K. and other state regulatory bodies;
  • Transcripts, slides and audiotapes from 6 webinars on supply chain issues offered by FDAnews in 2011, with more added periodically;
  • More than a dozen videos from FDAnews' 2011 Supplier Quality Summit and the Sixth Annual FDA Inspections Summit;
  • Blogs written by experts in supplier quality agreements, audits and other supply chain issues;
  • 10-plus templates and checklists you can use to develop your own supplier agreements and auditing plans;
  • 4 sample agreements between pharma companies and suppliers; and
  • Links to dozens of resources for developing supplier agreements, conducting audits and making sure your suppliers are towing the line within regulations.
Subscribing now guarantees that you'll immediately receive access to everything you need for keeping up-to-date with pharma supply chain issues no matter where you are. All the content is available exclusively on PharmaSupplyChain.com. BECOME A MEMBER! Joining now will give you immediate access to all the resources in the member's only section.
$747.00

Webinar Training Pass Subscription

 

We can’t provide you with more staff members or travel money to get to new training programs. But we can provide expert training for you in ONE place … without ever leaving your office.

Introducing FDAnews’ Webinar Training Pass

The Training Pass program gives you year-round unrestricted access to hundreds of web-based training programs, featuring top consultants, expert speakers and FDA officials.

Need training on a topic for your entire team? The Training Pass lets you train on your schedule – on the subjects you need most. Gather your entire team to view an archived webinar together OR let them view and listen on their own time.

Topics covered in these training webinars include social media, inspectional readiness, process validation, recalls, spreadsheet validation, Pharmacovigilance strategies, understanding biosimilars, insight on PDUFA V, adverse event compliance and reporting, QSR Data, supply chain risks and much more.

When you register for the Training Pass, you get instant on-demand access to our ever growing collection of webinars, AND access to all of our LIVE webinars for the life of your subscription.

You’ll automatically be registered for every webinar we host — we'll send dial-in instructions via email prior to every webinar and a monthly reminder of upcoming programs. You’ll always have access to our archive programs. All you have to do is dial in!

How Much Will Your New Training Pass Cost?

The Training Pass price is normally $1,297, but today you can get it for a LOW, introductory price of only $997. That’s a $300 savings!

That’s less than $10 for each archived webinar alone. Add in the live webinars you’ll have access to, during the year and the cost per training session drops even more.

Order yours now!

To Recap, Here’s What Your New Training Pass Gives You:

  1. Training from the best minds and thought leaders in the pharma, device and clinical industries.
  2. Wide variety of topics to help you stay in compliance with the FDA.
  3. Instant, on-demand unlimited access to all archived webinars for each member of your team.
  4. One automatic registration to every live webinar we’ll ever host for the life of your subscription. You can get additional lines for half price.
  5. Special Training Pass member discounts to live workshops and conferences.

Act now to purchase this limited time Training Pass offer, before our special promotional offer ends!

Get yours today!

Note: Your Training Pass allows you to have unlimited access to the archived and they can be viewed as many times as needed. You will receive a registration good for one dial-in to each live webinar over the life of your subscription.

$997.00

Webinar Training Pass Subscription

 

We can’t give you more staff members or travel money to get to new training programs. But we can provide expert training for you in ONE place … without ever leaving your office.

FDAnews’ Webinar Training Pass

The Training Pass program gives you year-round unrestricted access to hundreds of web-based training programs, featuring top consultants, expert speakers and FDA officials.

Topics covered in these training webinars include social media, GLP Auditing, inspectional readiness, process validation, recalls, spreadsheet validation, Pharmacovigilance strategies, understanding biosimilars, insight on PDUFA V, adverse event compliance and reporting, QSR Data, supply chain risks, financial disclosure requirements for clinical investigators and much more.

When you register for the Training Pass, you get instant on-demand access to our ever growing collection of webinars, AND access to all of our LIVE webinars for the life of your subscription.

You’ll automatically be registered for every webinar we host — we'll send dial-in instructions via email prior to every webinar and a monthly reminder of upcoming programs. You’ll always have access to our archive programs. All you have to do is dial in!

That’s less than $11 for each archived webinar alone. Add in the live webinars you’ll have access to, during the year and the cost per training session drops even more.

To Recap, Here’s What Your New Training Pass Gives You:

  1. Training from the best minds and thought leaders in the industry.
  2. Wide variety of topics to help you stay in compliance with the FDA.
  3. Instant, on-demand, unlimited access to all 120+ archived webinars and 40 new ones we’re working on.
  4. One automatic registration to every live webinar we’ll ever host for the life of your subscription. You can get additional lines for half price.
  5. Special Training Pass member discounts to live workshops and conferences.

Get yours today!

Note: Your Training Pass allows you to have unlimited access to the archived webinars which can be viewed as many times as needed. You will also receive a registration for one dial-in to each live webinar over the life of your subscription.

$1,297.00

483sOnline.com - One-Year Unlimited Access Renewal

It’s no secret: Form 483s are the best resources available to understand what FDA investigators are looking for today. In fact, by referring to the observations in recently-issued 483s, you can:

  • Prepare your own facility to withstand the inspection scrutiny;
  • Assess your competitors’ compliance;
  • Background potential business partners’ compliance records;
  • Learn from the mistakes of others and better manage your own manufacturing operations; and
  • Create training and quality improvement scenarios based on real-life findings.

There’s only one catch about 483s. It isn’t very easy or cost-effective to get them from the FDA. First, there’s the expense of using staff time to make your FOIA request … then the cost of each 483 … and finally the long wait before they actually arrive.

But now there’s a new, better way to acquire 483s.

With a subscription to 483sOnline.com, you get round-the-clock, unlimited access to more than two thousand recent 483s ... with new ones being added weekly. Need to find what you are looking for in a hurry? You can search by:

  • Company name
  • Date of Inspection
  • Inspector Name
  • Region
  • Keyword

And the 483s are ready for you to download instantly.

You even get a weekly email notice of the new 483s we've added, so you're sure never to miss a thing.

This subscription is for single user only. Licenses for multiple users and/or multiple locations are also available at significant discounts. For more information, contact Nelly Valentin at nvalentin@fdanews.com or (888) 838-5578.

$997.00

International Pharmaceutical Regulatory Monitor Renewal

International Pharmaceutical Regulatory Monitor

International Pharmaceutical Regulatory Monitor (IPRM) keeps pharma professionals on top of key changes in pharmaceutical regulation around the world, covering rules and standards from the FDA, the European Medicines Agency, Health Canada, Australia's TGA, the International Conference on Harmonisation and other agencies in Europe, Japan and elsewhere.

PLUS: in every issue, you get links to additional documents from international agencies and commissions that support IPRM’s articles, such as draft and final guidances, regulations and amendments, rules, court decisions, guidelines, procedures, explanatory notes and more.

With your subscription you’ll also receive:

  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
  • Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
  • FDAnews Drug Daily Bulletin. This daily email alert brings you important FDA and international regulatory, legislative and business news in the pharmaceutical industry.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with International Pharmaceutical Regulatory Monitor, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to International Pharmaceutical Regulatory Monitor today. It couldn’t be easier.

$895.00

International Medical Device Regulatory Monitor Renewal

International Medical Device Regulatory Monitor

International Medical Device Regulatory Monitor (IMDRM) tracks all the relevant topics – from clinical trials and listing requirements to marketing and manufacturing regulations – in the markets where you need to stay compliant. Our editors track long-established regulatory leaders, such as the EU, Japan and the U.S; important, fast-growing markets, such as Brazil, Russia, India and China; and smaller markets that are gradually strengthening their regulatory structure, such as the Middle Eastern nations.

PLUS: , in every issue, you get links to additional key documents from international agencies and commissions that support IMDRM’s articles, such as guidances, warning letters, rules, full texts of proposed legislation, regulations, papers, presentations, and more.

With your subscription you’ll also receive:

  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
  • Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
  • FDAnews Device Daily Bulletin. This daily email alert brings you important FDA and international regulatory, legislative and business news in the medical device industry.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with International Medical Device Regulatory Monitor, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to International Medical Device Regulatory Monitor today. It couldn’t be easier.

$799.00

The GMP Letter Renewal

The GMP Letter

The GMP Letter (GMP) to stay on top of the FDA's interpretation and enforcement of the quality systems regulation and to learn which changes they must make to stay in compliance. In each monthly issue, you get an update on key regulatory developments, tips on how to prepare for FDA inspections, proven ways to improve design control procedures, ideas to create more effective GMP training programs and more.

With a subscription to The GMP Letter, you’ll get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

Each issue provides:

  • New and draft FDA guidances;
  • Implications of new regulations
  • Reasons/causes for the most recent warning letters;
  • Updates on key regulatory developments;
  • Tips to prepare for FDA inspections;
  • Proven ways to improve design control procedures; and
  • Ideas to create more effective GMP training programs.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with The GMP Letter, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to The GMP Letter today. It couldn’t be easier.

$1,085.00

Drug Industry Daily Renewal

Drug Industry Daily

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators ... and what their competitors are up to.

Don't waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID's experienced in-house editorial team do the work for you. Use your energy where it's needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

PLUS: in every issue, you get links to additional documents that support DID’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug Industry Daily, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug Industry Daily today. It couldn’t be easier.

$1,695.00

Drug GMP Report Renewal

Drug GMP Report

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.

$1,045.00

Webinar Training Pass Renewal

 

We can’t give you more staff members or travel money to get to new training programs. But we can provide expert training for you in ONE place … without ever leaving your office.

FDAnews’ Webinar Training Pass

The Training Pass program gives you year-round unrestricted access to hundreds of web-based training programs, featuring top consultants, expert speakers and FDA officials.

Topics covered in these training webinars include social media, GLP Auditing, inspectional readiness, process validation, recalls, spreadsheet validation, Pharmacovigilance strategies, understanding biosimilars, insight on PDUFA V, adverse event compliance and reporting, QSR Data, supply chain risks, financial disclosure requirements for clinical investigators and much more.

When you register for the Training Pass, you get instant on-demand access to our ever growing collection of webinars, AND access to all of our LIVE webinars for the life of your subscription.

You’ll automatically be registered for every webinar we host — we'll send dial-in instructions via email prior to every webinar and a monthly reminder of upcoming programs. You’ll always have access to our archive programs. All you have to do is dial in!

That’s less than $11 for each archived webinar alone. Add in the live webinars you’ll have access to, during the year and the cost per training session drops even more.

To Recap, Here’s What Your New Training Pass Gives You:

  1. Training from the best minds and thought leaders in the industry.
  2. Wide variety of topics to help you stay in compliance with the FDA.
  3. Instant, on-demand, unlimited access to all 120+ archived webinars and 40 new ones we’re working on.
  4. One automatic registration to every live webinar we’ll ever host for the life of your subscription. You can get additional lines for half price.
  5. Special Training Pass member discounts to live workshops and conferences.

Get yours today!

Note: Your Training Pass allows you to have unlimited access to the archived webinars which can be viewed as many times as needed. You will also receive a registration for one dial-in to each live webinar over the life of your subscription.

$997.00

The GMP Letter - Save $150 On a One-Year Subscription

The GMP Letter

The GMP Letter (GMP) is your key to staying on top of the FDA's interpretation and enforcement of the quality systems regulation and to learn which changes they must make to stay in compliance. In each monthly issue, you get an update on key regulatory developments, tips on how to prepare for FDA inspections, proven ways to improve design control procedures, ideas to create more effective GMP training programs and more.

With a subscription to The GMP Letter, you’ll get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

Each issue provides:

  • New and draft FDA guidances;
  • Implications of new regulations
  • Reasons/causes for the most recent warning letters;
  • Updates on key regulatory developments;
  • Tips to prepare for FDA inspections;
  • Proven ways to improve design control procedures; and
  • Ideas to create more effective GMP training programs.

PLUS, you get links to key documents acquired by the FDAnews editorial staff, including actual 483s, warning letters, closeout letters, guidances, FDA notices, and many others.

BONUS:Renew your subscription NOW and save $150 off the regular one-year price of $997 — plus receive a FREE copy of our webinar CD, FDA’s New Generic Drug Safety Labeling Rule – a $347 value!

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with The GMP Letter, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to The GMP Letter today. It couldn’t be easier.

Monthly, 12 issues/year. Electronic Delivery

$835.00

The GMP Letter - Save $150 On a One-Year Subscription

The GMP Letter

The GMP Letter (GMP) is your key to staying on top of the FDA's interpretation and enforcement of the quality systems regulation and to learn which changes they must make to stay in compliance. In each monthly issue, you get an update on key regulatory developments, tips on how to prepare for FDA inspections, proven ways to improve design control procedures, ideas to create more effective GMP training programs and more.

With a subscription to The GMP Letter, you’ll get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

Each issue provides:

  • New and draft FDA guidances;
  • Implications of new regulations
  • Reasons/causes for the most recent warning letters;
  • Updates on key regulatory developments;
  • Tips to prepare for FDA inspections;
  • Proven ways to improve design control procedures; and
  • Ideas to create more effective GMP training programs.

PLUS, you get links to key documents acquired by the FDAnews editorial staff, including actual 483s, warning letters, closeout letters, guidances, FDA notices, and many others.

BONUS:Renew your subscription NOW and save $150 off the regular one-year price of $997 — plus receive a FREE copy of our webinar CD, FDA’s New Generic Drug Safety Labeling Rule – a $347 value!

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with The GMP Letter, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to The GMP Letter today. It couldn’t be easier.

Monthly, 12 issues/year. Electronic Delivery

$835.00

Drug GMP Report Subscription - Save $200 On a One-Year Subscription

Drug GMP Report

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.

$1,045.00
$845.00
$200.00 (19%)

Drug Industry Daily 6 Mo. Subscription

Drug Industry Daily

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators ... and what their competitors are up to.

Don't waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID's experienced in-house editorial team do the work for you. Use your energy where it's needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

PLUS: in every issue, you get links to additional documents that support DID’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug Industry Daily, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug Industry Daily today. It couldn’t be easier.

$797.00

Drug Industry Daily 3 Mo. Subscription

Drug Industry Daily

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators ... and what their competitors are up to.

Don't waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID's experienced in-house editorial team do the work for you. Use your energy where it's needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

PLUS: in every issue, you get links to additional documents that support DID’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug Industry Daily, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug Industry Daily today. It couldn’t be easier.

$445.00

Save $200 on One-Year Subscription to International Pharmaceutical Regulatory Monitor

International Pharmaceutical Regulatory Monitor

International Pharmaceutical Regulatory Monitor (IPRM) keeps pharma professionals on top of key changes in pharmaceutical regulation around the world, covering rules and standards from the FDA, the European Medicines Agency, Health Canada, Australia's TGA, the International Conference on Harmonisation and other agencies in Europe, Japan and elsewhere.

PLUS: in every issue, you get links to additional documents from international agencies and commissions that support IPRM’s articles, such as draft and final guidances, regulations and amendments, rules, court decisions, guidelines, procedures, explanatory notes and more.

With your subscription you’ll also receive:

  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
  • Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
  • FDAnews Drug Daily Bulletin. This daily email alert brings you important FDA and international regulatory, legislative and business news in the pharmaceutical industry.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with International Pharmaceutical Regulatory Monitor, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to International Pharmaceutical Regulatory Monitor today. It couldn’t be easier.

$695.00

483sOnline.com - One-Year Unlimited Access Subscription

483sOnline.com is your own personal pre-investigation intelligence tool that identifies exactly what investigators are focusing on before they show up.

483sOnline.com is more than just a library of 3,100 Form 483s.  It’s a tool you can use every day to help stay in compliance with FDA regulations. You can search:

  • By keyword or phrase: Search through all observations for each 483 — by the exact keyword or phrase you’re looking for, giving you the intelligence you need;
  • By date: Find out what issues the investigators have focused on in the recent past;

  • By company: Find out how things are going at companies just like yours;
     
  • By investigator name: Learn about the investigating trends of the official that’s likely to conduct your next inspection.

 

And the 483s are ready for you to download instantly.

You even get a weekly email notice of the new 483s we've added, so you're sure never to miss a thing.

This subscription offer is for one user only, but you're eligible for a significant discount on a multi-user and/or multi-location license. Get your entire company or department involved in scouring 483s for information that can help you with FDA inspections. For more information, contact us at (888) 838-5578.

$797.00

International Pharmaceutical Regulatory Monitor 2-Year Renewal

International Pharmaceutical Regulatory Monitor

International Pharmaceutical Regulatory Monitor (IPRM) keeps pharma professionals on top of key changes in pharmaceutical regulation around the world, covering rules and standards from the FDA, the European Medicines Agency, Health Canada, Australia's TGA, the International Conference on Harmonisation and other agencies in Europe, Japan and elsewhere.

PLUS: in every issue, you get links to additional documents from international agencies and commissions that support IPRM’s articles, such as draft and final guidances, regulations and amendments, rules, court decisions, guidelines, procedures, explanatory notes and more.

With your subscription you’ll also receive:

  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
  • Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
  • FDAnews Drug Daily Bulletin. This daily email alert brings you important FDA and international regulatory, legislative and business news in the pharmaceutical industry.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with International Pharmaceutical Regulatory Monitor, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to International Pharmaceutical Regulatory Monitor today. It couldn’t be easier.

$1,431.00

International Pharmaceutical Regulatory Monitor 2-Year Renewal

International Pharmaceutical Regulatory Monitor

International Pharmaceutical Regulatory Monitor (IPRM) keeps pharma professionals on top of key changes in pharmaceutical regulation around the world, covering rules and standards from the FDA, the European Medicines Agency, Health Canada, Australia's TGA, the International Conference on Harmonisation and other agencies in Europe, Japan and elsewhere.

PLUS: in every issue, you get links to additional documents from international agencies and commissions that support IPRM’s articles, such as draft and final guidances, regulations and amendments, rules, court decisions, guidelines, procedures, explanatory notes and more.

With your subscription you’ll also receive:

  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
  • Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
  • FDAnews Drug Daily Bulletin. This daily email alert brings you important FDA and international regulatory, legislative and business news in the pharmaceutical industry.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with International Pharmaceutical Regulatory Monitor, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to International Pharmaceutical Regulatory Monitor today. It couldn’t be easier.

$1,581.00

International Pharmaceutical Regulatory Monitor Renewal

International Pharmaceutical Regulatory Monitor

International Pharmaceutical Regulatory Monitor (IPRM) keeps pharma professionals on top of key changes in pharmaceutical regulation around the world, covering rules and standards from the FDA, the European Medicines Agency, Health Canada, Australia's TGA, the International Conference on Harmonisation and other agencies in Europe, Japan and elsewhere.

PLUS: in every issue, you get links to additional documents from international agencies and commissions that support IPRM’s articles, such as draft and final guidances, regulations and amendments, rules, court decisions, guidelines, procedures, explanatory notes and more.

With your subscription you’ll also receive:

  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
  • Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
  • FDAnews Drug Daily Bulletin. This daily email alert brings you important FDA and international regulatory, legislative and business news in the pharmaceutical industry.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with International Pharmaceutical Regulatory Monitor, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to International Pharmaceutical Regulatory Monitor today. It couldn’t be easier.

$870.00

The GMP Letter 2-Year Renewal

The GMP Letter

The GMP Letter (GMP) to stay on top of the FDA's interpretation and enforcement of the quality systems regulation and to learn which changes they must make to stay in compliance. In each monthly issue, you get an update on key regulatory developments, tips on how to prepare for FDA inspections, proven ways to improve design control procedures, ideas to create more effective GMP training programs and more.

With a subscription to The GMP Letter, you’ll get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

Each issue provides:

  • New and draft FDA guidances;
  • Implications of new regulations
  • Reasons/causes for the most recent warning letters;
  • Updates on key regulatory developments;
  • Tips to prepare for FDA inspections;
  • Proven ways to improve design control procedures; and
  • Ideas to create more effective GMP training programs.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with The GMP Letter, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to The GMP Letter today. It couldn’t be easier.

$1,773.00

The GMP Letter 2-Year Renewal

The GMP Letter

The GMP Letter (GMP) to stay on top of the FDA's interpretation and enforcement of the quality systems regulation and to learn which changes they must make to stay in compliance. In each monthly issue, you get an update on key regulatory developments, tips on how to prepare for FDA inspections, proven ways to improve design control procedures, ideas to create more effective GMP training programs and more.

With a subscription to The GMP Letter, you’ll get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

Each issue provides:

  • New and draft FDA guidances;
  • Implications of new regulations
  • Reasons/causes for the most recent warning letters;
  • Updates on key regulatory developments;
  • Tips to prepare for FDA inspections;
  • Proven ways to improve design control procedures; and
  • Ideas to create more effective GMP training programs.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with The GMP Letter, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to The GMP Letter today. It couldn’t be easier.

$1,823.00

The GMP Letter Renewal

The GMP Letter

The GMP Letter (GMP) to stay on top of the FDA's interpretation and enforcement of the quality systems regulation and to learn which changes they must make to stay in compliance. In each monthly issue, you get an update on key regulatory developments, tips on how to prepare for FDA inspections, proven ways to improve design control procedures, ideas to create more effective GMP training programs and more.

With a subscription to The GMP Letter, you’ll get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

Each issue provides:

  • New and draft FDA guidances;
  • Implications of new regulations
  • Reasons/causes for the most recent warning letters;
  • Updates on key regulatory developments;
  • Tips to prepare for FDA inspections;
  • Proven ways to improve design control procedures; and
  • Ideas to create more effective GMP training programs.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with The GMP Letter, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to The GMP Letter today. It couldn’t be easier.

$1,010.00

Drug GMP Report 2-Year Renewal

Drug GMP Report

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.

$1,791.00

Drug GMP Report 2-Year Renewal

Drug GMP Report

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.

$1,841.00

Drug GMP Report Renewal

Drug GMP Report

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.

$1,020.00

483sOnline.com - Two-Year Unlimited Access Renewal

It’s no secret: Form 483s are the best resources available to understand what FDA investigators are looking for today. In fact, by referring to the observations in recently-issued 483s, you can:

  • Prepare your own facility to withstand the inspection scrutiny;
  • Assess your competitors’ compliance;
  • Background potential business partners’ compliance records;
  • Learn from the mistakes of others and better manage your own manufacturing operations; and
  • Create training and quality improvement scenarios based on real-life findings.

There’s only one catch about 483s. It isn’t very easy or cost-effective to get them from the FDA. First, there’s the expense of using staff time to make your FOIA request … then the cost of each 483 … and finally the long wait before they actually arrive.

But now there’s a new, better way to acquire 483s.

With a subscription to 483sOnline.com, you get round-the-clock, unlimited access to more than two thousand recent 483s ... with new ones being added weekly. Need to find what you are looking for in a hurry? You can search by:

  • Company name
  • Date of Inspection
  • Inspector Name
  • Region
  • Keyword

And the 483s are ready for you to download instantly.

You even get a weekly email notice of the new 483s we've added, so you're sure never to miss a thing.

This subscription is for single user only. Licenses for multiple users and/or multiple locations are also available at significant discounts. For more information, contact Nelly Valentin at nvalentin@fdanews.com or (888) 838-5578.

$1,335.00

Drug Industry Daily 2-Year Renewal

Drug Industry Daily

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators ... and what their competitors are up to.

Don't waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID's experienced in-house editorial team do the work for you. Use your energy where it's needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

PLUS: in every issue, you get links to additional documents that support DID’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug Industry Daily, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug Industry Daily today. It couldn’t be easier.

$2,961.00

International Medical Device Regulatory Monitor 2-Year Renewal

International Medical Device Regulatory Monitor

International Medical Device Regulatory Monitor (IMDRM) tracks all the relevant topics – from clinical trials and listing requirements to marketing and manufacturing regulations – in the markets where you need to stay compliant. Our editors track long-established regulatory leaders, such as the EU, Japan and the U.S; important, fast-growing markets, such as Brazil, Russia, India and China; and smaller markets that are gradually strengthening their regulatory structure, such as the Middle Eastern nations.

PLUS: , in every issue, you get links to additional key documents from international agencies and commissions that support IMDRM’s articles, such as guidances, warning letters, rules, full texts of proposed legislation, regulations, papers, presentations, and more.

With your subscription you’ll also receive:

  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
  • Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
  • FDAnews Device Daily Bulletin. This daily email alert brings you important FDA and international regulatory, legislative and business news in the medical device industry.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with International Medical Device Regulatory Monitor, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to International Medical Device Regulatory Monitor today. It couldn’t be easier.

$1,438.00

International Medical Device Regulatory Monitor 2-Year Renewal

International Medical Device Regulatory Monitor

International Medical Device Regulatory Monitor (IMDRM) tracks all the relevant topics – from clinical trials and listing requirements to marketing and manufacturing regulations – in the markets where you need to stay compliant. Our editors track long-established regulatory leaders, such as the EU, Japan and the U.S; important, fast-growing markets, such as Brazil, Russia, India and China; and smaller markets that are gradually strengthening their regulatory structure, such as the Middle Eastern nations.

PLUS: , in every issue, you get links to additional key documents from international agencies and commissions that support IMDRM’s articles, such as guidances, warning letters, rules, full texts of proposed legislation, regulations, papers, presentations, and more.

With your subscription you’ll also receive:

  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
  • Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
  • FDAnews Device Daily Bulletin. This daily email alert brings you important FDA and international regulatory, legislative and business news in the medical device industry.

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$1,588.00

International Medical Device Regulatory Monitor Renewal

International Medical Device Regulatory Monitor

International Medical Device Regulatory Monitor (IMDRM) tracks all the relevant topics – from clinical trials and listing requirements to marketing and manufacturing regulations – in the markets where you need to stay compliant. Our editors track long-established regulatory leaders, such as the EU, Japan and the U.S; important, fast-growing markets, such as Brazil, Russia, India and China; and smaller markets that are gradually strengthening their regulatory structure, such as the Middle Eastern nations.

PLUS: , in every issue, you get links to additional key documents from international agencies and commissions that support IMDRM’s articles, such as guidances, warning letters, rules, full texts of proposed legislation, regulations, papers, presentations, and more.

With your subscription you’ll also receive:

  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
  • Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
  • FDAnews Device Daily Bulletin. This daily email alert brings you important FDA and international regulatory, legislative and business news in the medical device industry.

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$874.00

Drug Industry Daily 2-Year Renewal

Drug Industry Daily

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators ... and what their competitors are up to.

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Drug Industry Daily Renewal

Drug Industry Daily

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators ... and what their competitors are up to.

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FDAnews' 483s Online Membership

Product Description
$997.00

Inspection Insider Pro

Inspections Access including Form 483s
$1,497.00

Save $300 on One-Year Subscription to Drug Industry Daily

Drug Industry Daily

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators ... and what their competitors are up to.

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You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

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Drug GMP Report Renewal - W/Free Webinar

Drug GMP Report

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

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$995.00

Drug Industry Daily W/Free Webinar

Drug Industry Daily

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators ... and what their competitors are up to.

Don't waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID's experienced in-house editorial team do the work for you. Use your energy where it's needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

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$1,695.00

The GMP Letter Renewal W/Free Webinar

The GMP Letter

The GMP Letter (GMP) is your key to staying on top of the FDA's interpretation and enforcement of the quality systems regulation and to learn which changes they must make to stay in compliance. In each monthly issue, you get an update on key regulatory developments, tips on how to prepare for FDA inspections, proven ways to improve design control procedures, ideas to create more effective GMP training programs and more.

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  • New and draft FDA guidances;
  • Implications of new regulations
  • Reasons/causes for the most recent warning letters;
  • Updates on key regulatory developments;
  • Tips to prepare for FDA inspections;
  • Proven ways to improve design control procedures; and
  • Ideas to create more effective GMP training programs.

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Monthly, 12 issues/year. Electronic Delivery

$985.00

International Pharmaceutical Regulatory Monitor Renewal W/Free MR

International Pharmaceutical Regulatory Monitor

International Pharmaceutical Regulatory Monitor (IPRM) keeps pharma professionals on top of key changes in pharmaceutical regulation around the world, covering rules and standards from the FDA, the European Medicines Agency, Health Canada, Australia's TGA, the International Conference on Harmonisation and other agencies in Europe, Japan and elsewhere.

PLUS: in every issue, you get links to additional documents from international agencies and commissions that support IPRM’s articles, such as draft and final guidances, regulations and amendments, rules, court decisions, guidelines, procedures, explanatory notes and more.

With your subscription you’ll also receive:

  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
  • Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
  • FDAnews Drug Daily Bulletin. This daily email alert brings you important FDA and international regulatory, legislative and business news in the pharmaceutical industry.

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$795.00

The GMP Letter - Save $150 On a One-Year Subscription

The GMP Letter

The GMP Letter (GMP) is your key to staying on top of the FDA's interpretation and enforcement of the quality systems regulation and to learn which changes they must make to stay in compliance. In each monthly issue, you get an update on key regulatory developments, tips on how to prepare for FDA inspections, proven ways to improve design control procedures, ideas to create more effective GMP training programs and more.

With a subscription to The GMP Letter, you’ll get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

Each issue provides:

  • New and draft FDA guidances;
  • Implications of new regulations
  • Reasons/causes for the most recent warning letters;
  • Updates on key regulatory developments;
  • Tips to prepare for FDA inspections;
  • Proven ways to improve design control procedures; and
  • Ideas to create more effective GMP training programs.

PLUS, you get links to key documents acquired by the FDAnews editorial staff, including actual 483s, warning letters, closeout letters, guidances, FDA notices, and many others.

BONUS:Renew your subscription NOW and save $150 off the regular one-year price of $997 — plus receive a FREE copy of our webinar CD, FDA’s New Generic Drug Safety Labeling Rule – a $347 value!

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Monthly, 12 issues/year. Electronic Delivery

$835.00

Inspection Insider Membership

Product Description
$747.00

Inspection Insider Membership with Face to Face with FDA Investigators DVD

Product Description
$997.00

Drug Industry Daily 1-Year Renewal

Drug Industry Daily

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators ... and what their competitors are up to.

Don't waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID's experienced in-house editorial team do the work for you. Use your energy where it's needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

PLUS: in every issue, you get links to additional documents that support DID’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

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$1,695.00

Drug Industry Daily 2-Year Renewal

Drug Industry Daily

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators ... and what their competitors are up to.

Don't waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID's experienced in-house editorial team do the work for you. Use your energy where it's needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

PLUS: in every issue, you get links to additional documents that support DID’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

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The GMP Letter 2-Year Renewal

The GMP Letter

The GMP Letter (GMP) to stay on top of the FDA's interpretation and enforcement of the quality systems regulation and to learn which changes they must make to stay in compliance. In each monthly issue, you get an update on key regulatory developments, tips on how to prepare for FDA inspections, proven ways to improve design control procedures, ideas to create more effective GMP training programs and more.

With a subscription to The GMP Letter, you’ll get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

Each issue provides:

  • New and draft FDA guidances;
  • Implications of new regulations
  • Reasons/causes for the most recent warning letters;
  • Updates on key regulatory developments;
  • Tips to prepare for FDA inspections;
  • Proven ways to improve design control procedures; and
  • Ideas to create more effective GMP training programs.

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The GMP Letter 1-Year Renewal

The GMP Letter

The GMP Letter (GMP) to stay on top of the FDA's interpretation and enforcement of the quality systems regulation and to learn which changes they must make to stay in compliance. In each monthly issue, you get an update on key regulatory developments, tips on how to prepare for FDA inspections, proven ways to improve design control procedures, ideas to create more effective GMP training programs and more.

With a subscription to The GMP Letter, you’ll get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

Each issue provides:

  • New and draft FDA guidances;
  • Implications of new regulations
  • Reasons/causes for the most recent warning letters;
  • Updates on key regulatory developments;
  • Tips to prepare for FDA inspections;
  • Proven ways to improve design control procedures; and
  • Ideas to create more effective GMP training programs.

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$1,010.00

The GMP Letter 2-Year Renewal

The GMP Letter

The GMP Letter (GMP) to stay on top of the FDA's interpretation and enforcement of the quality systems regulation and to learn which changes they must make to stay in compliance. In each monthly issue, you get an update on key regulatory developments, tips on how to prepare for FDA inspections, proven ways to improve design control procedures, ideas to create more effective GMP training programs and more.

With a subscription to The GMP Letter, you’ll get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

Each issue provides:

  • New and draft FDA guidances;
  • Implications of new regulations
  • Reasons/causes for the most recent warning letters;
  • Updates on key regulatory developments;
  • Tips to prepare for FDA inspections;
  • Proven ways to improve design control procedures; and
  • Ideas to create more effective GMP training programs.

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$1,773.00

The GMP Letter 1-Year Renewal

The GMP Letter

The GMP Letter (GMP) to stay on top of the FDA's interpretation and enforcement of the quality systems regulation and to learn which changes they must make to stay in compliance. In each monthly issue, you get an update on key regulatory developments, tips on how to prepare for FDA inspections, proven ways to improve design control procedures, ideas to create more effective GMP training programs and more.

With a subscription to The GMP Letter, you’ll get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

Each issue provides:

  • New and draft FDA guidances;
  • Implications of new regulations
  • Reasons/causes for the most recent warning letters;
  • Updates on key regulatory developments;
  • Tips to prepare for FDA inspections;
  • Proven ways to improve design control procedures; and
  • Ideas to create more effective GMP training programs.

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$985.00

International Medical Device Regulatory Monitor 2-Year Renewal

International Medical Device Regulatory Monitor

International Medical Device Regulatory Monitor (IMDRM) tracks all the relevant topics – from clinical trials and listing requirements to marketing and manufacturing regulations – in the markets where you need to stay compliant. Our editors track long-established regulatory leaders, such as the EU, Japan and the U.S; important, fast-growing markets, such as Brazil, Russia, India and China; and smaller markets that are gradually strengthening their regulatory structure, such as the Middle Eastern nations.

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With your subscription you’ll also receive:

  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
  • Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
  • FDAnews Device Daily Bulletin. This daily email alert brings you important FDA and international regulatory, legislative and business news in the medical device industry.

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International Medical Device Regulatory Monito Renewal

International Medical Device Regulatory Monitor

International Medical Device Regulatory Monitor (IMDRM) tracks all the relevant topics – from clinical trials and listing requirements to marketing and manufacturing regulations – in the markets where you need to stay compliant. Our editors track long-established regulatory leaders, such as the EU, Japan and the U.S; important, fast-growing markets, such as Brazil, Russia, India and China; and smaller markets that are gradually strengthening their regulatory structure, such as the Middle Eastern nations.

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With your subscription you’ll also receive:

  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
  • Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
  • FDAnews Device Daily Bulletin. This daily email alert brings you important FDA and international regulatory, legislative and business news in the medical device industry.

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$799.00

International Medical Device Regulatory Monitor 2-Year Renewal

International Medical Device Regulatory Monitor

International Medical Device Regulatory Monitor (IMDRM) tracks all the relevant topics – from clinical trials and listing requirements to marketing and manufacturing regulations – in the markets where you need to stay compliant. Our editors track long-established regulatory leaders, such as the EU, Japan and the U.S; important, fast-growing markets, such as Brazil, Russia, India and China; and smaller markets that are gradually strengthening their regulatory structure, such as the Middle Eastern nations.

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With your subscription you’ll also receive:

  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
  • Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
  • FDAnews Device Daily Bulletin. This daily email alert brings you important FDA and international regulatory, legislative and business news in the medical device industry.

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$1,588.00

International Medical Device Regulatory Monitor Renewal

International Medical Device Regulatory Monitor

International Medical Device Regulatory Monitor (IMDRM) tracks all the relevant topics – from clinical trials and listing requirements to marketing and manufacturing regulations – in the markets where you need to stay compliant. Our editors track long-established regulatory leaders, such as the EU, Japan and the U.S; important, fast-growing markets, such as Brazil, Russia, India and China; and smaller markets that are gradually strengthening their regulatory structure, such as the Middle Eastern nations.

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With your subscription you’ll also receive:

  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
  • Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
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$874.00

International Pharmaceutical Regulatory Monitor 2-Year Renewal

International Pharmaceutical Regulatory Monitor

International Pharmaceutical Regulatory Monitor (IPRM) keeps pharma professionals on top of key changes in pharmaceutical regulation around the world, covering rules and standards from the FDA, the European Medicines Agency, Health Canada, Australia's TGA, the International Conference on Harmonisation and other agencies in Europe, Japan and elsewhere.

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  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
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International Pharmaceutical Regulatory Monitor 1-Year Renewal

International Pharmaceutical Regulatory Monitor

International Pharmaceutical Regulatory Monitor (IPRM) keeps pharma professionals on top of key changes in pharmaceutical regulation around the world, covering rules and standards from the FDA, the European Medicines Agency, Health Canada, Australia's TGA, the International Conference on Harmonisation and other agencies in Europe, Japan and elsewhere.

PLUS: in every issue, you get links to additional documents from international agencies and commissions that support IPRM’s articles, such as draft and final guidances, regulations and amendments, rules, court decisions, guidelines, procedures, explanatory notes and more.

With your subscription you’ll also receive:

  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
  • Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
  • FDAnews Drug Daily Bulletin. This daily email alert brings you important FDA and international regulatory, legislative and business news in the pharmaceutical industry.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with International Pharmaceutical Regulatory Monitor, you may cancel your subscription and receive a full refund. No questions asked.

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$795.00

International Pharmaceutical Regulatory Monitor 2-Year Renewal

International Pharmaceutical Regulatory Monitor

International Pharmaceutical Regulatory Monitor (IPRM) keeps pharma professionals on top of key changes in pharmaceutical regulation around the world, covering rules and standards from the FDA, the European Medicines Agency, Health Canada, Australia's TGA, the International Conference on Harmonisation and other agencies in Europe, Japan and elsewhere.

PLUS: in every issue, you get links to additional documents from international agencies and commissions that support IPRM’s articles, such as draft and final guidances, regulations and amendments, rules, court decisions, guidelines, procedures, explanatory notes and more.

With your subscription you’ll also receive:

  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
  • Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
  • FDAnews Drug Daily Bulletin. This daily email alert brings you important FDA and international regulatory, legislative and business news in the pharmaceutical industry.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with International Pharmaceutical Regulatory Monitor, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to International Pharmaceutical Regulatory Monitor today. It couldn’t be easier.

$1,581.00

International Pharmaceutical Regulatory Monitor 1-Year Renewal

International Pharmaceutical Regulatory Monitor

International Pharmaceutical Regulatory Monitor (IPRM) keeps pharma professionals on top of key changes in pharmaceutical regulation around the world, covering rules and standards from the FDA, the European Medicines Agency, Health Canada, Australia's TGA, the International Conference on Harmonisation and other agencies in Europe, Japan and elsewhere.

PLUS: in every issue, you get links to additional documents from international agencies and commissions that support IPRM’s articles, such as draft and final guidances, regulations and amendments, rules, court decisions, guidelines, procedures, explanatory notes and more.

With your subscription you’ll also receive:

  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
  • Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
  • FDAnews Drug Daily Bulletin. This daily email alert brings you important FDA and international regulatory, legislative and business news in the pharmaceutical industry.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with International Pharmaceutical Regulatory Monitor, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to International Pharmaceutical Regulatory Monitor today. It couldn’t be easier.

$870.00

Drug GMP Report 2-Year Renewal

Drug GMP Report

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.

$1,791.00

Drug GMP Report 1-Year Renewal

Drug GMP Report

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.

$995.00

Drug GMP Report 2-Year Renewal

Drug GMP Report

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.

$1,841.00

Drug GMP Report 1-Year Renewal

Drug GMP Report

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.

$1,020.00

483sOnline.com - One-Year Unlimited Access Renewal

It’s no secret: Form 483s are the best resources available to understand what FDA investigators are looking for today. In fact, by referring to the observations in recently-issued 483s, you can:

  • Prepare your own facility to withstand the inspection scrutiny;
  • Assess your competitors’ compliance;
  • Background potential business partners’ compliance records;
  • Learn from the mistakes of others and better manage your own manufacturing operations; and
  • Create training and quality improvement scenarios based on real-life findings.

There’s only one catch about 483s. It isn’t very easy or cost-effective to get them from the FDA. First, there’s the expense of using staff time to make your FOIA request … then the cost of each 483 … and finally the long wait before they actually arrive.

But now there’s a new, better way to acquire 483s.

With a subscription to 483sOnline.com, you get round-the-clock, unlimited access to more than two thousand recent 483s ... with new ones being added weekly. Need to find what you are looking for in a hurry? You can search by:

  • Company name
  • Date of Inspection
  • Inspector Name
  • Region
  • Keyword

And the 483s are ready for you to download instantly.

You even get a weekly email notice of the new 483s we've added, so you're sure never to miss a thing.

This subscription is for single user only. Licenses for multiple users and/or multiple locations are also available at significant discounts. For more information, contact Nelly Valentin at nvalentin@fdanews.com or (888) 838-5578.

$997.00

483sOnline.com - Two-Year Unlimited Access Renewal

It’s no secret: Form 483s are the best resources available to understand what FDA investigators are looking for today. In fact, by referring to the observations in recently-issued 483s, you can:

  • Prepare your own facility to withstand the inspection scrutiny;
  • Assess your competitors’ compliance;
  • Background potential business partners’ compliance records;
  • Learn from the mistakes of others and better manage your own manufacturing operations; and
  • Create training and quality improvement scenarios based on real-life findings.

There’s only one catch about 483s. It isn’t very easy or cost-effective to get them from the FDA. First, there’s the expense of using staff time to make your FOIA request … then the cost of each 483 … and finally the long wait before they actually arrive.

But now there’s a new, better way to acquire 483s.

With a subscription to 483sOnline.com, you get round-the-clock, unlimited access to more than two thousand recent 483s ... with new ones being added weekly. Need to find what you are looking for in a hurry? You can search by:

  • Company name
  • Date of Inspection
  • Inspector Name
  • Region
  • Keyword

And the 483s are ready for you to download instantly.

You even get a weekly email notice of the new 483s we've added, so you're sure never to miss a thing.

This subscription is for single user only. Licenses for multiple users and/or multiple locations are also available at significant discounts. For more information, contact Nelly Valentin at nvalentin@fdanews.com or (888) 838-5578.

$1,795.00

Webinar Training Pass 1-Year Renewal

 

We can’t give you more staff members or travel money to get to new training programs. But we can provide expert training for you in ONE place … without ever leaving your office.

FDAnews’ Webinar Training Pass

The Training Pass program gives you year-round unrestricted access to hundreds of web-based training programs, featuring top consultants, expert speakers and FDA officials.

Topics covered in these training webinars include social media, GLP Auditing, inspectional readiness, process validation, recalls, spreadsheet validation, Pharmacovigilance strategies, understanding biosimilars, insight on PDUFA V, adverse event compliance and reporting, QSR Data, supply chain risks, financial disclosure requirements for clinical investigators and much more.

When you register for the Training Pass, you get instant on-demand access to our ever growing collection of webinars, AND access to all of our LIVE webinars for the life of your subscription.

You’ll automatically be registered for every webinar we host — we'll send dial-in instructions via email prior to every webinar and a monthly reminder of upcoming programs. You’ll always have access to our archive programs. All you have to do is dial in!

That’s less than $11 for each archived webinar alone. Add in the live webinars you’ll have access to, during the year and the cost per training session drops even more.

To Recap, Here’s What Your New Training Pass Gives You:

  1. Training from the best minds and thought leaders in the industry.
  2. Wide variety of topics to help you stay in compliance with the FDA.
  3. Instant, on-demand, unlimited access to all 120+ archived webinars and 40 new ones we’re working on.
  4. One automatic registration to every live webinar we’ll ever host for the life of your subscription. You can get additional lines for half price.
  5. Special Training Pass member discounts to live workshops and conferences.

Get yours today!

Note: Your Training Pass allows you to have unlimited access to the archived webinars which can be viewed as many times as needed. You will also receive a registration for one dial-in to each live webinar over the life of your subscription.

$997.00

Webinar Training Pass 2-Year Renewal

 

We can’t give you more staff members or travel money to get to new training programs. But we can provide expert training for you in ONE place … without ever leaving your office.

FDAnews’ Webinar Training Pass

The Training Pass program gives you year-round unrestricted access to hundreds of web-based training programs, featuring top consultants, expert speakers and FDA officials.

Topics covered in these training webinars include social media, GLP Auditing, inspectional readiness, process validation, recalls, spreadsheet validation, Pharmacovigilance strategies, understanding biosimilars, insight on PDUFA V, adverse event compliance and reporting, QSR Data, supply chain risks, financial disclosure requirements for clinical investigators and much more.

When you register for the Training Pass, you get instant on-demand access to our ever growing collection of webinars, AND access to all of our LIVE webinars for the life of your subscription.

You’ll automatically be registered for every webinar we host — we'll send dial-in instructions via email prior to every webinar and a monthly reminder of upcoming programs. You’ll always have access to our archive programs. All you have to do is dial in!

That’s less than $11 for each archived webinar alone. Add in the live webinars you’ll have access to, during the year and the cost per training session drops even more.

To Recap, Here’s What Your New Training Pass Gives You:

  1. Training from the best minds and thought leaders in the industry.
  2. Wide variety of topics to help you stay in compliance with the FDA.
  3. Instant, on-demand, unlimited access to all 120+ archived webinars and 40 new ones we’re working on.
  4. One automatic registration to every live webinar we’ll ever host for the life of your subscription. You can get additional lines for half price.
  5. Special Training Pass member discounts to live workshops and conferences.

Get yours today!

Note: Your Training Pass allows you to have unlimited access to the archived webinars which can be viewed as many times as needed. You will also receive a registration for one dial-in to each live webinar over the life of your subscription.

$1,795.00

The GMP Letter 1-Year Renewal

The GMP Letter

The GMP Letter (GMP) to stay on top of the FDA's interpretation and enforcement of the quality systems regulation and to learn which changes they must make to stay in compliance. In each monthly issue, you get an update on key regulatory developments, tips on how to prepare for FDA inspections, proven ways to improve design control procedures, ideas to create more effective GMP training programs and more.

With a subscription to The GMP Letter, you’ll get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

Each issue provides:

  • New and draft FDA guidances;
  • Implications of new regulations
  • Reasons/causes for the most recent warning letters;
  • Updates on key regulatory developments;
  • Tips to prepare for FDA inspections;
  • Proven ways to improve design control procedures; and
  • Ideas to create more effective GMP training programs.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with The GMP Letter, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to The GMP Letter today. It couldn’t be easier.

$685.00

Drug GMP Report 1-Year Renewal

Drug GMP Report

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.

$695.00

Drug Industry Daily 1-Year Renewal

Drug Industry Daily

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators ... and what their competitors are up to.

Don't waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID's experienced in-house editorial team do the work for you. Use your energy where it's needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

PLUS: in every issue, you get links to additional documents that support DID’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug Industry Daily, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug Industry Daily today. It couldn’t be easier.

$848.00

483sOnline.com - One-Year Unlimited Access Renewal

It’s no secret: Form 483s are the best resources available to understand what FDA investigators are looking for today. In fact, by referring to the observations in recently-issued 483s, you can:

  • Prepare your own facility to withstand the inspection scrutiny;
  • Assess your competitors’ compliance;
  • Background potential business partners’ compliance records;
  • Learn from the mistakes of others and better manage your own manufacturing operations; and
  • Create training and quality improvement scenarios based on real-life findings.

There’s only one catch about 483s. It isn’t very easy or cost-effective to get them from the FDA. First, there’s the expense of using staff time to make your FOIA request … then the cost of each 483 … and finally the long wait before they actually arrive.

But now there’s a new, better way to acquire 483s.

With a subscription to 483sOnline.com, you get round-the-clock, unlimited access to more than two thousand recent 483s ... with new ones being added weekly. Need to find what you are looking for in a hurry? You can search by:

  • Company name
  • Date of Inspection
  • Inspector Name
  • Region
  • Keyword

And the 483s are ready for you to download instantly.

You even get a weekly email notice of the new 483s we've added, so you're sure never to miss a thing.

This subscription is for single user only. Licenses for multiple users and/or multiple locations are also available at significant discounts. For more information, contact Nelly Valentin at nvalentin@fdanews.com or (888) 838-5578.

$697.00

International Medical Device Regulatory Monitor Renewal

International Medical Device Regulatory Monitor

International Medical Device Regulatory Monitor (IMDRM) tracks all the relevant topics – from clinical trials and listing requirements to marketing and manufacturing regulations – in the markets where you need to stay compliant. Our editors track long-established regulatory leaders, such as the EU, Japan and the U.S; important, fast-growing markets, such as Brazil, Russia, India and China; and smaller markets that are gradually strengthening their regulatory structure, such as the Middle Eastern nations.

PLUS: , in every issue, you get links to additional key documents from international agencies and commissions that support IMDRM’s articles, such as guidances, warning letters, rules, full texts of proposed legislation, regulations, papers, presentations, and more.

With your subscription you’ll also receive:

  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
  • Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
  • FDAnews Device Daily Bulletin. This daily email alert brings you important FDA and international regulatory, legislative and business news in the medical device industry.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with International Medical Device Regulatory Monitor, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to International Medical Device Regulatory Monitor today. It couldn’t be easier.

$499.00

International Pharmaceutical Regulatory Monitor 1-Year Renewal

International Pharmaceutical Regulatory Monitor

International Pharmaceutical Regulatory Monitor (IPRM) keeps pharma professionals on top of key changes in pharmaceutical regulation around the world, covering rules and standards from the FDA, the European Medicines Agency, Health Canada, Australia's TGA, the International Conference on Harmonisation and other agencies in Europe, Japan and elsewhere.

PLUS: in every issue, you get links to additional documents from international agencies and commissions that support IPRM’s articles, such as draft and final guidances, regulations and amendments, rules, court decisions, guidelines, procedures, explanatory notes and more.

With your subscription you’ll also receive:

  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
  • Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
  • FDAnews Drug Daily Bulletin. This daily email alert brings you important FDA and international regulatory, legislative and business news in the pharmaceutical industry.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with International Pharmaceutical Regulatory Monitor, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to International Pharmaceutical Regulatory Monitor today. It couldn’t be easier.

$495.00

Webinar Training Pass 1-Year Renewal

 

We can’t give you more staff members or travel money to get to new training programs. But we can provide expert training for you in ONE place … without ever leaving your office.

FDAnews’ Webinar Training Pass

The Training Pass program gives you year-round unrestricted access to hundreds of web-based training programs, featuring top consultants, expert speakers and FDA officials.

Topics covered in these training webinars include social media, GLP Auditing, inspectional readiness, process validation, recalls, spreadsheet validation, Pharmacovigilance strategies, understanding biosimilars, insight on PDUFA V, adverse event compliance and reporting, QSR Data, supply chain risks, financial disclosure requirements for clinical investigators and much more.

When you register for the Training Pass, you get instant on-demand access to our ever growing collection of webinars, AND access to all of our LIVE webinars for the life of your subscription.

You’ll automatically be registered for every webinar we host — we'll send dial-in instructions via email prior to every webinar and a monthly reminder of upcoming programs. You’ll always have access to our archive programs. All you have to do is dial in!

That’s less than $11 for each archived webinar alone. Add in the live webinars you’ll have access to, during the year and the cost per training session drops even more.

To Recap, Here’s What Your New Training Pass Gives You:

  1. Training from the best minds and thought leaders in the industry.
  2. Wide variety of topics to help you stay in compliance with the FDA.
  3. Instant, on-demand, unlimited access to all 120+ archived webinars and 40 new ones we’re working on.
  4. One automatic registration to every live webinar we’ll ever host for the life of your subscription. You can get additional lines for half price.
  5. Special Training Pass member discounts to live workshops and conferences.

Get yours today!

Note: Your Training Pass allows you to have unlimited access to the archived webinars which can be viewed as many times as needed. You will also receive a registration for one dial-in to each live webinar over the life of your subscription.

$697.00

Inspection Insider Membership with Face to Face with FDA Investigators DVD

Product Description
$897.00

The GMP Letter - Save $150 On a One-Year Subscription

The GMP Letter

The GMP Letter (GMP) is your key to staying on top of the FDA's interpretation and enforcement of the quality systems regulation and to learn which changes they must make to stay in compliance. In each monthly issue, you get an update on key regulatory developments, tips on how to prepare for FDA inspections, proven ways to improve design control procedures, ideas to create more effective GMP training programs and more.

With a subscription to The GMP Letter, you’ll get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

Each issue provides:

  • New and draft FDA guidances;
  • Implications of new regulations
  • Reasons/causes for the most recent warning letters;
  • Updates on key regulatory developments;
  • Tips to prepare for FDA inspections;
  • Proven ways to improve design control procedures; and
  • Ideas to create more effective GMP training programs.

PLUS, you get links to key documents acquired by the FDAnews editorial staff, including actual 483s, warning letters, closeout letters, guidances, FDA notices, and many others.

BONUS:Renew your subscription NOW and save $150 off the regular one-year price of $997 — plus receive a FREE copy of our webinar CD, Preparing for an FDA Inspection – a $347 value!

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with The GMP Letter, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to The GMP Letter today. It couldn’t be easier.

Monthly, 12 issues/year. Electronic Delivery

$835.00

483sOnline.com - 50% Off One-Year Unlimited Access Subscription

483sOnline.com is more than just a library of 3,100 Form 483s. It's a tool you can use every day to help you stay in compliance with FDA regulations. You can search:

  • By keyword or phrase: Search through all observations for each 483 - by the exact keyword of phrase you're looking for, giving you the intelligence you need;
     
  • By date: Find out what issues the investigators have focused on in the recent past;
     
  • By company: Find out how things are going at companies just like yours;
     
  • By investigator name: Learn about investigating trends of the official that's likely to conduct your next inspection.

Unlike other services our database us updated weekly - our staff continuously monitor all FDA investigator activity and requests all corresponding 483s.

 

With a subscription to 483sOnline.com, you get round-the-clock, unlimited access to more than 3,100 recent 483s … with new ones constantly being added. And as a special bonus, you get a weekly email listing all the 483s added to the database that week.

This subscription is for single user only. Licenses for multiple users and/or multiple locations are also available at significant discounts. For more information, contact Nelly Valentin at nvalentin@fdanews.com or (888) 838-5578.

$498.50

International Devices & Diagnostics Monitor 1 Year Subscription

Product Description
$1,247.00

International Devices & Diagnostics Monitor 1 Year Subscription

Product Description
$947.00

International Devices & Diagnostics Monitor Renewal

Product Description
$1,247.00

Inspection Insider Membership Renewal

Product Description
$997.00

Inspection Insider Plus 483sOnline Membership Renewal

Product Description
$1,395.00

International Devices & Diagnostics Monitor Renewal

Product Description
$747.00

Inspection Insider Membership Renewal

Product Description
$997.00

The GMP Letter 1-Year Renewal

The GMP Letter

The GMP Letter (GMP) to stay on top of the FDA's interpretation and enforcement of the quality systems regulation and to learn which changes they must make to stay in compliance. In each monthly issue, you get an update on key regulatory developments, tips on how to prepare for FDA inspections, proven ways to improve design control procedures, ideas to create more effective GMP training programs and more.

With a subscription to The GMP Letter, you’ll get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

Each issue provides:

  • New and draft FDA guidances;
  • Implications of new regulations
  • Reasons/causes for the most recent warning letters;
  • Updates on key regulatory developments;
  • Tips to prepare for FDA inspections;
  • Proven ways to improve design control procedures; and
  • Ideas to create more effective GMP training programs.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with The GMP Letter, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to The GMP Letter today. It couldn’t be easier.

$985.00

International Devices & Diagnostics Monitor 1 Year Subscription

Product Description
$947.00

Drug GMP Report Subscription - Save $150 On a One-Year Subscription

Drug GMP Report

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.

$1,045.00
$895.00
$150.00 (14%)

The GMP Letter - Save $200 On a One-Year Subscription

The GMP Letter

The GMP Letter (GMP) is your key to staying on top of the FDA's interpretation and enforcement of the quality systems regulation and to learn which changes they must make to stay in compliance. In each monthly issue, you get an update on key regulatory developments, tips on how to prepare for FDA inspections, proven ways to improve design control procedures, ideas to create more effective GMP training programs and more.

With a subscription to The GMP Letter, you’ll get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

Each issue provides:

  • New and draft FDA guidances;
  • Implications of new regulations
  • Reasons/causes for the most recent warning letters;
  • Updates on key regulatory developments;
  • Tips to prepare for FDA inspections;
  • Proven ways to improve design control procedures; and
  • Ideas to create more effective GMP training programs.

PLUS, you get links to key documents acquired by the FDAnews editorial staff, including actual 483s, warning letters, closeout letters, guidances, FDA notices, and many others.

BONUS:Renew your subscription NOW and save $150 off the regular one-year price of $997 — plus receive a FREE copy of our webinar CD, FDA’s New Generic Drug Safety Labeling Rule – a $347 value!

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with The GMP Letter, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to The GMP Letter today. It couldn’t be easier.

Monthly, 12 issues/year. Electronic Delivery

$885.00

Inspection Insider Membership $300 Off One Year Price

Product Description
$697.00

The GMP Letter - Save $150 On a One-Year Subscription

The GMP Letter

The GMP Letter (GMP) is your key to staying on top of the FDA's interpretation and enforcement of the quality systems regulation and to learn which changes they must make to stay in compliance. In each monthly issue, you get an update on key regulatory developments, tips on how to prepare for FDA inspections, proven ways to improve design control procedures, ideas to create more effective GMP training programs and more.

With a subscription to The GMP Letter, you’ll get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

Each issue provides:

  • New and draft FDA guidances;
  • Implications of new regulations
  • Reasons/causes for the most recent warning letters;
  • Updates on key regulatory developments;
  • Tips to prepare for FDA inspections;
  • Proven ways to improve design control procedures; and
  • Ideas to create more effective GMP training programs.

PLUS, you get links to key documents acquired by the FDAnews editorial staff, including actual 483s, warning letters, closeout letters, guidances, FDA notices, and many others.

BONUS:Renew your subscription NOW and save $150 off the regular one-year price of $997 — plus receive a FREE copy of our webinar CD, FDA’s New Generic Drug Safety Labeling Rule – a $347 value!

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with The GMP Letter, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to The GMP Letter today. It couldn’t be easier.

Monthly, 12 issues/year. Electronic Delivery

$935.00

Drug GMP Report 1-Year Renewal W/Free Report

Drug GMP Report

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.

$995.00

Drug GMP Report 2-Year Renewal W/Free Report

Drug GMP Report

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.

$1,791.00

Drug GMP Report 2-Year Renewal W/Free Report

Drug GMP Report

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.

$1,841.00

Drug GMP Report 1-Year Renewal W/Free Report

Drug GMP Report

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.

$1,020.00

International Pharmaceutical Regulatory Monitor 2-Year Renewal W/Free Webinar

International Pharmaceutical Regulatory Monitor

International Pharmaceutical Regulatory Monitor (IPRM) keeps pharma professionals on top of key changes in pharmaceutical regulation around the world, covering rules and standards from the FDA, the European Medicines Agency, Health Canada, Australia's TGA, the International Conference on Harmonisation and other agencies in Europe, Japan and elsewhere.

PLUS: in every issue, you get links to additional documents from international agencies and commissions that support IPRM’s articles, such as draft and final guidances, regulations and amendments, rules, court decisions, guidelines, procedures, explanatory notes and more.

With your subscription you’ll also receive:

  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
  • Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
  • FDAnews Drug Daily Bulletin. This daily email alert brings you important FDA and international regulatory, legislative and business news in the pharmaceutical industry.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with International Pharmaceutical Regulatory Monitor, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to International Pharmaceutical Regulatory Monitor today. It couldn’t be easier.

$1,431.00

International Pharmaceutical Regulatory Monitor 1-Year Renewal W/Free Webinar

International Pharmaceutical Regulatory Monitor

International Pharmaceutical Regulatory Monitor (IPRM) keeps pharma professionals on top of key changes in pharmaceutical regulation around the world, covering rules and standards from the FDA, the European Medicines Agency, Health Canada, Australia's TGA, the International Conference on Harmonisation and other agencies in Europe, Japan and elsewhere.

PLUS: in every issue, you get links to additional documents from international agencies and commissions that support IPRM’s articles, such as draft and final guidances, regulations and amendments, rules, court decisions, guidelines, procedures, explanatory notes and more.

With your subscription you’ll also receive:

  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
  • Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
  • FDAnews Drug Daily Bulletin. This daily email alert brings you important FDA and international regulatory, legislative and business news in the pharmaceutical industry.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with International Pharmaceutical Regulatory Monitor, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to International Pharmaceutical Regulatory Monitor today. It couldn’t be easier.

$1,431.00

International Pharmaceutical Regulatory Monitor 2-Year Renewal W/Free Webinar

International Pharmaceutical Regulatory Monitor

International Pharmaceutical Regulatory Monitor (IPRM) keeps pharma professionals on top of key changes in pharmaceutical regulation around the world, covering rules and standards from the FDA, the European Medicines Agency, Health Canada, Australia's TGA, the International Conference on Harmonisation and other agencies in Europe, Japan and elsewhere.

PLUS: in every issue, you get links to additional documents from international agencies and commissions that support IPRM’s articles, such as draft and final guidances, regulations and amendments, rules, court decisions, guidelines, procedures, explanatory notes and more.

With your subscription you’ll also receive:

  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
  • Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
  • FDAnews Drug Daily Bulletin. This daily email alert brings you important FDA and international regulatory, legislative and business news in the pharmaceutical industry.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with International Pharmaceutical Regulatory Monitor, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to International Pharmaceutical Regulatory Monitor today. It couldn’t be easier.

$1,581.00

Drug Industry Daily 2-Year Renewal W/Free Management Report

Drug Industry Daily

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators ... and what their competitors are up to.

Don't waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID's experienced in-house editorial team do the work for you. Use your energy where it's needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

PLUS: in every issue, you get links to additional documents that support DID’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug Industry Daily, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug Industry Daily today. It couldn’t be easier.

$2,961.00

Drug Industry Daily 1-Year Renewal W/Free Management Report

Drug Industry Daily

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators ... and what their competitors are up to.

Don't waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID's experienced in-house editorial team do the work for you. Use your energy where it's needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

PLUS: in every issue, you get links to additional documents that support DID’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug Industry Daily, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug Industry Daily today. It couldn’t be easier.

$1,645.00

The GMP Letter 1-Year Renewal W/Free Webinar CD

The GMP Letter

The GMP Letter (GMP) to stay on top of the FDA's interpretation and enforcement of the quality systems regulation and to learn which changes they must make to stay in compliance. In each monthly issue, you get an update on key regulatory developments, tips on how to prepare for FDA inspections, proven ways to improve design control procedures, ideas to create more effective GMP training programs and more.

With a subscription to The GMP Letter, you’ll get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

Each issue provides:

  • New and draft FDA guidances;
  • Implications of new regulations
  • Reasons/causes for the most recent warning letters;
  • Updates on key regulatory developments;
  • Tips to prepare for FDA inspections;
  • Proven ways to improve design control procedures; and
  • Ideas to create more effective GMP training programs.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with The GMP Letter, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to The GMP Letter today. It couldn’t be easier.

$985.00

The GMP Letter 1-Year Renewal W/Free Management Report

The GMP Letter

The GMP Letter (GMP) to stay on top of the FDA's interpretation and enforcement of the quality systems regulation and to learn which changes they must make to stay in compliance. In each monthly issue, you get an update on key regulatory developments, tips on how to prepare for FDA inspections, proven ways to improve design control procedures, ideas to create more effective GMP training programs and more.

With a subscription to The GMP Letter, you’ll get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

Each issue provides:

  • New and draft FDA guidances;
  • Implications of new regulations
  • Reasons/causes for the most recent warning letters;
  • Updates on key regulatory developments;
  • Tips to prepare for FDA inspections;
  • Proven ways to improve design control procedures; and
  • Ideas to create more effective GMP training programs.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with The GMP Letter, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to The GMP Letter today. It couldn’t be easier.

$1,010.00

Webinar Training Pass 2-Year Renewal W/Management Report

 

We can’t give you more staff members or travel money to get to new training programs. But we can provide expert training for you in ONE place … without ever leaving your office.

FDAnews’ Webinar Training Pass

The Training Pass program gives you year-round unrestricted access to hundreds of web-based training programs, featuring top consultants, expert speakers and FDA officials.

Topics covered in these training webinars include social media, GLP Auditing, inspectional readiness, process validation, recalls, spreadsheet validation, Pharmacovigilance strategies, understanding biosimilars, insight on PDUFA V, adverse event compliance and reporting, QSR Data, supply chain risks, financial disclosure requirements for clinical investigators and much more.

When you register for the Training Pass, you get instant on-demand access to our ever growing collection of webinars, AND access to all of our LIVE webinars for the life of your subscription.

You’ll automatically be registered for every webinar we host — we'll send dial-in instructions via email prior to every webinar and a monthly reminder of upcoming programs. You’ll always have access to our archive programs. All you have to do is dial in!

That’s less than $11 for each archived webinar alone. Add in the live webinars you’ll have access to, during the year and the cost per training session drops even more.

To Recap, Here’s What Your New Training Pass Gives You:

  1. Training from the best minds and thought leaders in the industry.
  2. Wide variety of topics to help you stay in compliance with the FDA.
  3. Instant, on-demand, unlimited access to all 120+ archived webinars and 40 new ones we’re working on.
  4. One automatic registration to every live webinar we’ll ever host for the life of your subscription. You can get additional lines for half price.
  5. Special Training Pass member discounts to live workshops and conferences.

Get yours today!

Note: Your Training Pass allows you to have unlimited access to the archived webinars which can be viewed as many times as needed. You will also receive a registration for one dial-in to each live webinar over the life of your subscription.

$1,795.00

Webinar Training Pass 1-Year Renewal W/Management Report

 

We can’t give you more staff members or travel money to get to new training programs. But we can provide expert training for you in ONE place … without ever leaving your office.

FDAnews’ Webinar Training Pass

The Training Pass program gives you year-round unrestricted access to hundreds of web-based training programs, featuring top consultants, expert speakers and FDA officials.

Topics covered in these training webinars include social media, GLP Auditing, inspectional readiness, process validation, recalls, spreadsheet validation, Pharmacovigilance strategies, understanding biosimilars, insight on PDUFA V, adverse event compliance and reporting, QSR Data, supply chain risks, financial disclosure requirements for clinical investigators and much more.

When you register for the Training Pass, you get instant on-demand access to our ever growing collection of webinars, AND access to all of our LIVE webinars for the life of your subscription.

You’ll automatically be registered for every webinar we host — we'll send dial-in instructions via email prior to every webinar and a monthly reminder of upcoming programs. You’ll always have access to our archive programs. All you have to do is dial in!

That’s less than $11 for each archived webinar alone. Add in the live webinars you’ll have access to, during the year and the cost per training session drops even more.

To Recap, Here’s What Your New Training Pass Gives You:

  1. Training from the best minds and thought leaders in the industry.
  2. Wide variety of topics to help you stay in compliance with the FDA.
  3. Instant, on-demand, unlimited access to all 120+ archived webinars and 40 new ones we’re working on.
  4. One automatic registration to every live webinar we’ll ever host for the life of your subscription. You can get additional lines for half price.
  5. Special Training Pass member discounts to live workshops and conferences.

Get yours today!

Note: Your Training Pass allows you to have unlimited access to the archived webinars which can be viewed as many times as needed. You will also receive a registration for one dial-in to each live webinar over the life of your subscription.

$997.00

483sOnline.com - Two-Year Unlimited Access Renewal W/Free Management Report

It’s no secret: Form 483s are the best resources available to understand what FDA investigators are looking for today. In fact, by referring to the observations in recently-issued 483s, you can:

  • Prepare your own facility to withstand the inspection scrutiny;
  • Assess your competitors’ compliance;
  • Background potential business partners’ compliance records;
  • Learn from the mistakes of others and better manage your own manufacturing operations; and
  • Create training and quality improvement scenarios based on real-life findings.

There’s only one catch about 483s. It isn’t very easy or cost-effective to get them from the FDA. First, there’s the expense of using staff time to make your FOIA request … then the cost of each 483 … and finally the long wait before they actually arrive.

But now there’s a new, better way to acquire 483s.

With a subscription to 483sOnline.com, you get round-the-clock, unlimited access to more than two thousand recent 483s ... with new ones being added weekly. Need to find what you are looking for in a hurry? You can search by:

  • Company name
  • Date of Inspection
  • Inspector Name
  • Region
  • Keyword

And the 483s are ready for you to download instantly.

You even get a weekly email notice of the new 483s we've added, so you're sure never to miss a thing.

This subscription is for single user only. Licenses for multiple users and/or multiple locations are also available at significant discounts. For more information, contact Nelly Valentin at nvalentin@fdanews.com or (888) 838-5578.

$1,795.00

483sOnline.com - One-Year Unlimited Access Renewal W/Free Management Report

It’s no secret: Form 483s are the best resources available to understand what FDA investigators are looking for today. In fact, by referring to the observations in recently-issued 483s, you can:

  • Prepare your own facility to withstand the inspection scrutiny;
  • Assess your competitors’ compliance;
  • Background potential business partners’ compliance records;
  • Learn from the mistakes of others and better manage your own manufacturing operations; and
  • Create training and quality improvement scenarios based on real-life findings.

There’s only one catch about 483s. It isn’t very easy or cost-effective to get them from the FDA. First, there’s the expense of using staff time to make your FOIA request … then the cost of each 483 … and finally the long wait before they actually arrive.

But now there’s a new, better way to acquire 483s.

With a subscription to 483sOnline.com, you get round-the-clock, unlimited access to more than two thousand recent 483s ... with new ones being added weekly. Need to find what you are looking for in a hurry? You can search by:

  • Company name
  • Date of Inspection
  • Inspector Name
  • Region
  • Keyword

And the 483s are ready for you to download instantly.

You even get a weekly email notice of the new 483s we've added, so you're sure never to miss a thing.

This subscription is for single user only. Licenses for multiple users and/or multiple locations are also available at significant discounts. For more information, contact Nelly Valentin at nvalentin@fdanews.com or (888) 838-5578.

$997.00

Inspection Insider 1 Year Renewal W/Management Report

Product Description
$997.00

Inspection Insider 2 Year Renewal W/Management Report

Product Description
$1,795.00

International Devices & Diagnostics Monitor Renewal

Product Description
$1,197.00

International Devices & Diagnostics Monitor Renewal

Product Description
$2,155.00

International Devices & Diagnostics Monitor Renewal

Product Description
$799.00

International Devices & Diagnostics Monitor Renewal

Product Description
$1,438.00

Save $100 on One-Year Subscription to International Pharmaceutical Regulatory Monitor

International Pharmaceutical Regulatory Monitor

International Pharmaceutical Regulatory Monitor (IPRM) keeps pharma professionals on top of key changes in pharmaceutical regulation around the world, covering rules and standards from the FDA, the European Medicines Agency, Health Canada, Australia's TGA, the International Conference on Harmonisation and other agencies in Europe, Japan and elsewhere.

PLUS: in every issue, you get links to additional documents from international agencies and commissions that support IPRM’s articles, such as draft and final guidances, regulations and amendments, rules, court decisions, guidelines, procedures, explanatory notes and more.

With your subscription you’ll also receive:

  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
  • Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
  • FDAnews Drug Daily Bulletin. This daily email alert brings you important FDA and international regulatory, legislative and business news in the pharmaceutical industry.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with International Pharmaceutical Regulatory Monitor, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to International Pharmaceutical Regulatory Monitor today. It couldn’t be easier.

$795.00

483sOnline.com - Save $200 on a One Year Subscription

483sOnline.com is your own personal pre-investigation intelligence tool that identifies exactly what investigators are focusing on before they show up.

483sOnline.com is more than just a library of 3,100 Form 483s.  It’s a tool you can use every day to help stay in compliance with FDA regulations. You can search:

  • By keyword or phrase: Search through all observations for each 483 — by the exact keyword or phrase you’re looking for, giving you the intelligence you need;
  • By date: Find out what issues the investigators have focused on in the recent past;

  • By company: Find out how things are going at companies just like yours;
     
  • By investigator name: Learn about the investigating trends of the official that’s likely to conduct your next inspection.

 

And the 483s are ready for you to download instantly.

You even get a weekly email notice of the new 483s we've added, so you're sure never to miss a thing.

This subscription offer is for one user only, but you're eligible for a significant discount on a multi-user and/or multi-location license. Get your entire company or department involved in scouring 483s for information that can help you with FDA inspections. For more information, contact us at (888) 838-5578.

$797.00

The GMP Letter - Save $200 On a One-Year Subscription

The GMP Letter

The GMP Letter (GMP) is your key to staying on top of the FDA's interpretation and enforcement of the quality systems regulation and to learn which changes they must make to stay in compliance. In each monthly issue, you get an update on key regulatory developments, tips on how to prepare for FDA inspections, proven ways to improve design control procedures, ideas to create more effective GMP training programs and more.

With a subscription to The GMP Letter, you’ll get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

Each issue provides:

  • New and draft FDA guidances;
  • Implications of new regulations
  • Reasons/causes for the most recent warning letters;
  • Updates on key regulatory developments;
  • Tips to prepare for FDA inspections;
  • Proven ways to improve design control procedures; and
  • Ideas to create more effective GMP training programs.

PLUS, you get links to key documents acquired by the FDAnews editorial staff, including actual 483s, warning letters, closeout letters, guidances, FDA notices, and many others.

BONUS:Renew your subscription NOW and save $150 off the regular one-year price of $997 — plus receive a FREE copy of our webinar CD, FDA’s New Generic Drug Safety Labeling Rule – a $347 value!

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with The GMP Letter, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to The GMP Letter today. It couldn’t be easier.

Monthly, 12 issues/year. Electronic Delivery

$885.00

Inspection Insider Membership

Product Description
$697.00

Webinar Training Pass 1-Year Renewal

 

We can’t give you more staff members or travel money to get to new training programs. But we can provide expert training for you in ONE place … without ever leaving your office.

FDAnews’ Webinar Training Pass

The Training Pass program gives you year-round unrestricted access to hundreds of web-based training programs, featuring top consultants, expert speakers and FDA officials.

Topics covered in these training webinars include social media, GLP Auditing, inspectional readiness, process validation, recalls, spreadsheet validation, Pharmacovigilance strategies, understanding biosimilars, insight on PDUFA V, adverse event compliance and reporting, QSR Data, supply chain risks, financial disclosure requirements for clinical investigators and much more.

When you register for the Training Pass, you get instant on-demand access to our ever growing collection of webinars, AND access to all of our LIVE webinars for the life of your subscription.

You’ll automatically be registered for every webinar we host — we'll send dial-in instructions via email prior to every webinar and a monthly reminder of upcoming programs. You’ll always have access to our archive programs. All you have to do is dial in!

That’s less than $11 for each archived webinar alone. Add in the live webinars you’ll have access to, during the year and the cost per training session drops even more.

To Recap, Here’s What Your New Training Pass Gives You:

  1. Training from the best minds and thought leaders in the industry.
  2. Wide variety of topics to help you stay in compliance with the FDA.
  3. Instant, on-demand, unlimited access to all 120+ archived webinars and 40 new ones we’re working on.
  4. One automatic registration to every live webinar we’ll ever host for the life of your subscription. You can get additional lines for half price.
  5. Special Training Pass member discounts to live workshops and conferences.

Get yours today!

Note: Your Training Pass allows you to have unlimited access to the archived webinars which can be viewed as many times as needed. You will also receive a registration for one dial-in to each live webinar over the life of your subscription.

$697.00

The GMP Letter 1-Year Renewal

The GMP Letter

The GMP Letter (GMP) to stay on top of the FDA's interpretation and enforcement of the quality systems regulation and to learn which changes they must make to stay in compliance. In each monthly issue, you get an update on key regulatory developments, tips on how to prepare for FDA inspections, proven ways to improve design control procedures, ideas to create more effective GMP training programs and more.

With a subscription to The GMP Letter, you’ll get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

Each issue provides:

  • New and draft FDA guidances;
  • Implications of new regulations
  • Reasons/causes for the most recent warning letters;
  • Updates on key regulatory developments;
  • Tips to prepare for FDA inspections;
  • Proven ways to improve design control procedures; and
  • Ideas to create more effective GMP training programs.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with The GMP Letter, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to The GMP Letter today. It couldn’t be easier.

$685.00

Save $400 on One-Year Subscription to Drug Industry Daily

Drug Industry Daily

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators ... and what their competitors are up to.

Don't waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID's experienced in-house editorial team do the work for you. Use your energy where it's needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

PLUS: in every issue, you get links to additional documents that support DID’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug Industry Daily, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug Industry Daily today. It couldn’t be easier.

$1,295.00

Drug GMP Report 1-Year Renewal

Drug GMP Report

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.

$695.00

Drug Industry Daily 1-Year Renewal

Drug Industry Daily

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators ... and what their competitors are up to.

Don't waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID's experienced in-house editorial team do the work for you. Use your energy where it's needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

PLUS: in every issue, you get links to additional documents that support DID’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug Industry Daily, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug Industry Daily today. It couldn’t be easier.

$847.00

Inspection Insider 1-Year Membership

Product Description
$397.00

Inspection Insider 1-Year Membership

Product Description
$697.00

International Pharmaceutical Regulatory Monitor 1-Year Renewal

International Pharmaceutical Regulatory Monitor

International Pharmaceutical Regulatory Monitor (IPRM) keeps pharma professionals on top of key changes in pharmaceutical regulation around the world, covering rules and standards from the FDA, the European Medicines Agency, Health Canada, Australia's TGA, the International Conference on Harmonisation and other agencies in Europe, Japan and elsewhere.

PLUS: in every issue, you get links to additional documents from international agencies and commissions that support IPRM’s articles, such as draft and final guidances, regulations and amendments, rules, court decisions, guidelines, procedures, explanatory notes and more.

With your subscription you’ll also receive:

  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
  • Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
  • FDAnews Drug Daily Bulletin. This daily email alert brings you important FDA and international regulatory, legislative and business news in the pharmaceutical industry.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with International Pharmaceutical Regulatory Monitor, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to International Pharmaceutical Regulatory Monitor today. It couldn’t be easier.

$495.00

483sOnline.com - One-Year Unlimited Access Renewal

It’s no secret: Form 483s are the best resources available to understand what FDA investigators are looking for today. In fact, by referring to the observations in recently-issued 483s, you can:

  • Prepare your own facility to withstand the inspection scrutiny;
  • Assess your competitors’ compliance;
  • Background potential business partners’ compliance records;
  • Learn from the mistakes of others and better manage your own manufacturing operations; and
  • Create training and quality improvement scenarios based on real-life findings.

There’s only one catch about 483s. It isn’t very easy or cost-effective to get them from the FDA. First, there’s the expense of using staff time to make your FOIA request … then the cost of each 483 … and finally the long wait before they actually arrive.

But now there’s a new, better way to acquire 483s.

With a subscription to 483sOnline.com, you get round-the-clock, unlimited access to more than two thousand recent 483s ... with new ones being added weekly. Need to find what you are looking for in a hurry? You can search by:

  • Company name
  • Date of Inspection
  • Inspector Name
  • Region
  • Keyword

And the 483s are ready for you to download instantly.

You even get a weekly email notice of the new 483s we've added, so you're sure never to miss a thing.

This subscription is for single user only. Licenses for multiple users and/or multiple locations are also available at significant discounts. For more information, contact Nelly Valentin at nvalentin@fdanews.com or (888) 838-5578.

$697.00

International Devices & Diagnostics Monitor 1 Year Subscription

Product Description
$947.00

Drug GMP Report Subscription - Save $200 On a One-Year Subscription

Drug GMP Report

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.

$1,045.00
$845.00
$200.00 (19%)

International Devices & Diagnostics Monitor 1 Year Subscription

Product Description
$747.00

Drug GMP Report Subscription - Save $200 On a One-Year Subscription

Drug GMP Report

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.

$1,045.00
$845.00
$200.00 (19%)

Drug GMP Report Subscription - Save $400 On a One-Year Subscription

Drug GMP Report

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.

$1,045.00
$645.00
$400.00 (38%)

International Devices & Diagnostics Monitor 1 Year Subscription

Product Description
$847.00

Inspection Insider 1 Year Renewal W/DVD

Product Description
$997.00

Inspection Insider 2 Year Renewal W/DVD

Product Description
$1,795.00

Drug GMP Report 1-Year Renewal W/Webinar CD

Drug GMP Report

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.

$995.00

Drug GMP Report 2-Year Renewal W/Webinar CD

Drug GMP Report

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.

$1,791.00

The GMP Letter 2-Year Renewal W/Free Webinar CD

The GMP Letter

The GMP Letter (GMP) to stay on top of the FDA's interpretation and enforcement of the quality systems regulation and to learn which changes they must make to stay in compliance. In each monthly issue, you get an update on key regulatory developments, tips on how to prepare for FDA inspections, proven ways to improve design control procedures, ideas to create more effective GMP training programs and more.

With a subscription to The GMP Letter, you’ll get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

Each issue provides:

  • New and draft FDA guidances;
  • Implications of new regulations
  • Reasons/causes for the most recent warning letters;
  • Updates on key regulatory developments;
  • Tips to prepare for FDA inspections;
  • Proven ways to improve design control procedures; and
  • Ideas to create more effective GMP training programs.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with The GMP Letter, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to The GMP Letter today. It couldn’t be easier.

$1,773.00

Webinar Training Pass 2-Year Renewal W/DVD

 

We can’t give you more staff members or travel money to get to new training programs. But we can provide expert training for you in ONE place … without ever leaving your office.

FDAnews’ Webinar Training Pass

The Training Pass program gives you year-round unrestricted access to hundreds of web-based training programs, featuring top consultants, expert speakers and FDA officials.

Topics covered in these training webinars include social media, GLP Auditing, inspectional readiness, process validation, recalls, spreadsheet validation, Pharmacovigilance strategies, understanding biosimilars, insight on PDUFA V, adverse event compliance and reporting, QSR Data, supply chain risks, financial disclosure requirements for clinical investigators and much more.

When you register for the Training Pass, you get instant on-demand access to our ever growing collection of webinars, AND access to all of our LIVE webinars for the life of your subscription.

You’ll automatically be registered for every webinar we host — we'll send dial-in instructions via email prior to every webinar and a monthly reminder of upcoming programs. You’ll always have access to our archive programs. All you have to do is dial in!

That’s less than $11 for each archived webinar alone. Add in the live webinars you’ll have access to, during the year and the cost per training session drops even more.

To Recap, Here’s What Your New Training Pass Gives You:

  1. Training from the best minds and thought leaders in the industry.
  2. Wide variety of topics to help you stay in compliance with the FDA.
  3. Instant, on-demand, unlimited access to all 120+ archived webinars and 40 new ones we’re working on.
  4. One automatic registration to every live webinar we’ll ever host for the life of your subscription. You can get additional lines for half price.
  5. Special Training Pass member discounts to live workshops and conferences.

Get yours today!

Note: Your Training Pass allows you to have unlimited access to the archived webinars which can be viewed as many times as needed. You will also receive a registration for one dial-in to each live webinar over the life of your subscription.

$1,795.00

Webinar Training Pass 1-Year Renewal W/DVD

 

We can’t give you more staff members or travel money to get to new training programs. But we can provide expert training for you in ONE place … without ever leaving your office.

FDAnews’ Webinar Training Pass

The Training Pass program gives you year-round unrestricted access to hundreds of web-based training programs, featuring top consultants, expert speakers and FDA officials.

Topics covered in these training webinars include social media, GLP Auditing, inspectional readiness, process validation, recalls, spreadsheet validation, Pharmacovigilance strategies, understanding biosimilars, insight on PDUFA V, adverse event compliance and reporting, QSR Data, supply chain risks, financial disclosure requirements for clinical investigators and much more.

When you register for the Training Pass, you get instant on-demand access to our ever growing collection of webinars, AND access to all of our LIVE webinars for the life of your subscription.

You’ll automatically be registered for every webinar we host — we'll send dial-in instructions via email prior to every webinar and a monthly reminder of upcoming programs. You’ll always have access to our archive programs. All you have to do is dial in!

That’s less than $11 for each archived webinar alone. Add in the live webinars you’ll have access to, during the year and the cost per training session drops even more.

To Recap, Here’s What Your New Training Pass Gives You:

  1. Training from the best minds and thought leaders in the industry.
  2. Wide variety of topics to help you stay in compliance with the FDA.
  3. Instant, on-demand, unlimited access to all 120+ archived webinars and 40 new ones we’re working on.
  4. One automatic registration to every live webinar we’ll ever host for the life of your subscription. You can get additional lines for half price.
  5. Special Training Pass member discounts to live workshops and conferences.

Get yours today!

Note: Your Training Pass allows you to have unlimited access to the archived webinars which can be viewed as many times as needed. You will also receive a registration for one dial-in to each live webinar over the life of your subscription.

$997.00

483sOnline.com - Two-Year Unlimited Access Renewal W/DVD

It’s no secret: Form 483s are the best resources available to understand what FDA investigators are looking for today. In fact, by referring to the observations in recently-issued 483s, you can:

  • Prepare your own facility to withstand the inspection scrutiny;
  • Assess your competitors’ compliance;
  • Background potential business partners’ compliance records;
  • Learn from the mistakes of others and better manage your own manufacturing operations; and
  • Create training and quality improvement scenarios based on real-life findings.

There’s only one catch about 483s. It isn’t very easy or cost-effective to get them from the FDA. First, there’s the expense of using staff time to make your FOIA request … then the cost of each 483 … and finally the long wait before they actually arrive.

But now there’s a new, better way to acquire 483s.

With a subscription to 483sOnline.com, you get round-the-clock, unlimited access to more than two thousand recent 483s ... with new ones being added weekly. Need to find what you are looking for in a hurry? You can search by:

  • Company name
  • Date of Inspection
  • Inspector Name
  • Region
  • Keyword

And the 483s are ready for you to download instantly.

You even get a weekly email notice of the new 483s we've added, so you're sure never to miss a thing.

This subscription is for single user only. Licenses for multiple users and/or multiple locations are also available at significant discounts. For more information, contact Nelly Valentin at nvalentin@fdanews.com or (888) 838-5578.

$1,795.00

483sOnline.com - One-Year Unlimited Access Renewal W/DVD

It’s no secret: Form 483s are the best resources available to understand what FDA investigators are looking for today. In fact, by referring to the observations in recently-issued 483s, you can:

  • Prepare your own facility to withstand the inspection scrutiny;
  • Assess your competitors’ compliance;
  • Background potential business partners’ compliance records;
  • Learn from the mistakes of others and better manage your own manufacturing operations; and
  • Create training and quality improvement scenarios based on real-life findings.

There’s only one catch about 483s. It isn’t very easy or cost-effective to get them from the FDA. First, there’s the expense of using staff time to make your FOIA request … then the cost of each 483 … and finally the long wait before they actually arrive.

But now there’s a new, better way to acquire 483s.

With a subscription to 483sOnline.com, you get round-the-clock, unlimited access to more than two thousand recent 483s ... with new ones being added weekly. Need to find what you are looking for in a hurry? You can search by:

  • Company name
  • Date of Inspection
  • Inspector Name
  • Region
  • Keyword

And the 483s are ready for you to download instantly.

You even get a weekly email notice of the new 483s we've added, so you're sure never to miss a thing.

This subscription is for single user only. Licenses for multiple users and/or multiple locations are also available at significant discounts. For more information, contact Nelly Valentin at nvalentin@fdanews.com or (888) 838-5578.

$997.00

Drug Industry Daily 2-Year Renewal W/Webinar CD

Drug Industry Daily

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators ... and what their competitors are up to.

Don't waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID's experienced in-house editorial team do the work for you. Use your energy where it's needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

PLUS: in every issue, you get links to additional documents that support DID’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug Industry Daily, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug Industry Daily today. It couldn’t be easier.

$2,961.00

Drug Industry Daily 1-Year Renewal W/Webinar CD

Drug Industry Daily

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators ... and what their competitors are up to.

Don't waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID's experienced in-house editorial team do the work for you. Use your energy where it's needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

PLUS: in every issue, you get links to additional documents that support DID’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug Industry Daily, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug Industry Daily today. It couldn’t be easier.

$1,645.00

International Pharmaceutical Regulatory Monitor 2-Year Renewal W/CD

International Pharmaceutical Regulatory Monitor

International Pharmaceutical Regulatory Monitor (IPRM) keeps pharma professionals on top of key changes in pharmaceutical regulation around the world, covering rules and standards from the FDA, the European Medicines Agency, Health Canada, Australia's TGA, the International Conference on Harmonisation and other agencies in Europe, Japan and elsewhere.

PLUS: in every issue, you get links to additional documents from international agencies and commissions that support IPRM’s articles, such as draft and final guidances, regulations and amendments, rules, court decisions, guidelines, procedures, explanatory notes and more.

With your subscription you’ll also receive:

  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
  • Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
  • FDAnews Drug Daily Bulletin. This daily email alert brings you important FDA and international regulatory, legislative and business news in the pharmaceutical industry.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with International Pharmaceutical Regulatory Monitor, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to International Pharmaceutical Regulatory Monitor today. It couldn’t be easier.

$1,581.00

International Pharmaceutical Regulatory Monitor 1-Year Renewal W/CD

International Pharmaceutical Regulatory Monitor

International Pharmaceutical Regulatory Monitor (IPRM) keeps pharma professionals on top of key changes in pharmaceutical regulation around the world, covering rules and standards from the FDA, the European Medicines Agency, Health Canada, Australia's TGA, the International Conference on Harmonisation and other agencies in Europe, Japan and elsewhere.

PLUS: in every issue, you get links to additional documents from international agencies and commissions that support IPRM’s articles, such as draft and final guidances, regulations and amendments, rules, court decisions, guidelines, procedures, explanatory notes and more.

With your subscription you’ll also receive:

  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
  • Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
  • FDAnews Drug Daily Bulletin. This daily email alert brings you important FDA and international regulatory, legislative and business news in the pharmaceutical industry.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with International Pharmaceutical Regulatory Monitor, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to International Pharmaceutical Regulatory Monitor today. It couldn’t be easier.

$870.00

International Pharmaceutical Regulatory Monitor 2-Year Renewal W/CD

International Pharmaceutical Regulatory Monitor

International Pharmaceutical Regulatory Monitor (IPRM) keeps pharma professionals on top of key changes in pharmaceutical regulation around the world, covering rules and standards from the FDA, the European Medicines Agency, Health Canada, Australia's TGA, the International Conference on Harmonisation and other agencies in Europe, Japan and elsewhere.

PLUS: in every issue, you get links to additional documents from international agencies and commissions that support IPRM’s articles, such as draft and final guidances, regulations and amendments, rules, court decisions, guidelines, procedures, explanatory notes and more.

With your subscription you’ll also receive:

  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
  • Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
  • FDAnews Drug Daily Bulletin. This daily email alert brings you important FDA and international regulatory, legislative and business news in the pharmaceutical industry.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with International Pharmaceutical Regulatory Monitor, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to International Pharmaceutical Regulatory Monitor today. It couldn’t be easier.

$1,431.00

International Pharmaceutical Regulatory Monitor 1-Year Renewal W/CD

International Pharmaceutical Regulatory Monitor

International Pharmaceutical Regulatory Monitor (IPRM) keeps pharma professionals on top of key changes in pharmaceutical regulation around the world, covering rules and standards from the FDA, the European Medicines Agency, Health Canada, Australia's TGA, the International Conference on Harmonisation and other agencies in Europe, Japan and elsewhere.

PLUS: in every issue, you get links to additional documents from international agencies and commissions that support IPRM’s articles, such as draft and final guidances, regulations and amendments, rules, court decisions, guidelines, procedures, explanatory notes and more.

With your subscription you’ll also receive:

  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
  • Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
  • FDAnews Drug Daily Bulletin. This daily email alert brings you important FDA and international regulatory, legislative and business news in the pharmaceutical industry.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with International Pharmaceutical Regulatory Monitor, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to International Pharmaceutical Regulatory Monitor today. It couldn’t be easier.

$1,431.00

The GMP Letter 2-Year Renewal W/Free Webinar CD

The GMP Letter

The GMP Letter (GMP) to stay on top of the FDA's interpretation and enforcement of the quality systems regulation and to learn which changes they must make to stay in compliance. In each monthly issue, you get an update on key regulatory developments, tips on how to prepare for FDA inspections, proven ways to improve design control procedures, ideas to create more effective GMP training programs and more.

With a subscription to The GMP Letter, you’ll get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

Each issue provides:

  • New and draft FDA guidances;
  • Implications of new regulations
  • Reasons/causes for the most recent warning letters;
  • Updates on key regulatory developments;
  • Tips to prepare for FDA inspections;
  • Proven ways to improve design control procedures; and
  • Ideas to create more effective GMP training programs.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with The GMP Letter, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to The GMP Letter today. It couldn’t be easier.

$1,823.00

The GMP Letter 1-Year Renewal W/Webinar CD

The GMP Letter

The GMP Letter (GMP) to stay on top of the FDA's interpretation and enforcement of the quality systems regulation and to learn which changes they must make to stay in compliance. In each monthly issue, you get an update on key regulatory developments, tips on how to prepare for FDA inspections, proven ways to improve design control procedures, ideas to create more effective GMP training programs and more.

With a subscription to The GMP Letter, you’ll get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

Each issue provides:

  • New and draft FDA guidances;
  • Implications of new regulations
  • Reasons/causes for the most recent warning letters;
  • Updates on key regulatory developments;
  • Tips to prepare for FDA inspections;
  • Proven ways to improve design control procedures; and
  • Ideas to create more effective GMP training programs.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with The GMP Letter, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to The GMP Letter today. It couldn’t be easier.

$1,010.00

Drug GMP Report 2-Year Renewal W/Free Webinar CD

Drug GMP Report

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.

$1,841.00

Drug GMP Report 1-Year Renewal W/Webinar CD

Drug GMP Report

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.

$1,020.00

Drug Industry Daily 1-Year Renewal W/Webinar CD

Drug Industry Daily

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators ... and what their competitors are up to.

Don't waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID's experienced in-house editorial team do the work for you. Use your energy where it's needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

PLUS: in every issue, you get links to additional documents that support DID’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug Industry Daily, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug Industry Daily today. It couldn’t be easier.

$1,345.00

Drug Industry Daily 2-Year Renewal W/Webinar CD

Drug Industry Daily

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators ... and what their competitors are up to.

Don't waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID's experienced in-house editorial team do the work for you. Use your energy where it's needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

PLUS: in every issue, you get links to additional documents that support DID’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug Industry Daily, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug Industry Daily today. It couldn’t be easier.

$2,421.00

Drug GMP Report Subscription - Save $200 On a One-Year Subscription

Drug GMP Report

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.

$1,045.00
$845.00
$200.00 (19%)

Drug GMP Report Subscription - Save $200 On a One-Year Subscription

Drug GMP Report

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.

$1,045.00
$845.00
$200.00 (19%)

483sOnline.com - One-Year Unlimited Access Subscription

483sOnline.com is your own personal pre-investigation intelligence tool that identifies exactly what investigators are focusing on before they show up.

483sOnline.com is more than just a library of 3,100 Form 483s.  It’s a tool you can use every day to help stay in compliance with FDA regulations. You can search:

  • By keyword or phrase: Search through all observations for each 483 — by the exact keyword or phrase you’re looking for, giving you the intelligence you need;
  • By date: Find out what issues the investigators have focused on in the recent past;

  • By company: Find out how things are going at companies just like yours;
     
  • By investigator name: Learn about the investigating trends of the official that’s likely to conduct your next inspection.

 

And the 483s are ready for you to download instantly.

You even get a weekly email notice of the new 483s we've added, so you're sure never to miss a thing.

This subscription offer is for one user only, but you're eligible for a significant discount on a multi-user and/or multi-location license. Get your entire company or department involved in scouring 483s for information that can help you with FDA inspections. For more information, contact us at (888) 838-5578.

$797.00

The GMP Letter - Save $200 On a One-Year Subscription

The GMP Letter

The GMP Letter (GMP) is your key to staying on top of the FDA's interpretation and enforcement of the quality systems regulation and to learn which changes they must make to stay in compliance. In each monthly issue, you get an update on key regulatory developments, tips on how to prepare for FDA inspections, proven ways to improve design control procedures, ideas to create more effective GMP training programs and more.

With a subscription to The GMP Letter, you’ll get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

Each issue provides:

  • New and draft FDA guidances;
  • Implications of new regulations
  • Reasons/causes for the most recent warning letters;
  • Updates on key regulatory developments;
  • Tips to prepare for FDA inspections;
  • Proven ways to improve design control procedures; and
  • Ideas to create more effective GMP training programs.

PLUS, you get links to key documents acquired by the FDAnews editorial staff, including actual 483s, warning letters, closeout letters, guidances, FDA notices, and many others.

BONUS:Renew your subscription NOW and save $150 off the regular one-year price of $997 — plus receive a FREE copy of our webinar CD, FDA’s New Generic Drug Safety Labeling Rule – a $347 value!

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with The GMP Letter, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to The GMP Letter today. It couldn’t be easier.

Monthly, 12 issues/year. Electronic Delivery

$885.00

483sOnline.com - One-Year Unlimited Access Subscription W/Webinar CD

483sOnline.com is your own personal pre-investigation intelligence tool that identifies exactly what investigators are focusing on before they show up.

483sOnline.com is more than just a library of 3,100 Form 483s.  It’s a tool you can use every day to help stay in compliance with FDA regulations. You can search:

  • By keyword or phrase: Search through all observations for each 483 — by the exact keyword or phrase you’re looking for, giving you the intelligence you need;
  • By date: Find out what issues the investigators have focused on in the recent past;

  • By company: Find out how things are going at companies just like yours;
     
  • By investigator name: Learn about the investigating trends of the official that’s likely to conduct your next inspection.

 

And the 483s are ready for you to download instantly.

You even get a weekly email notice of the new 483s we've added, so you're sure never to miss a thing.

This subscription offer is for one user only, but you're eligible for a significant discount on a multi-user and/or multi-location license. Get your entire company or department involved in scouring 483s for information that can help you with FDA inspections. For more information, contact us at (888) 838-5578.

$797.00

Drug GMP Report Subscription - Save $200 On a One-Year Subscription

Drug GMP Report

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.

$1,045.00
$845.00
$200.00 (19%)

The GMP Letter - Save $200 On a One-Year Subscription

The GMP Letter

The GMP Letter (GMP) is your key to staying on top of the FDA's interpretation and enforcement of the quality systems regulation and to learn which changes they must make to stay in compliance. In each monthly issue, you get an update on key regulatory developments, tips on how to prepare for FDA inspections, proven ways to improve design control procedures, ideas to create more effective GMP training programs and more.

With a subscription to The GMP Letter, you’ll get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

Each issue provides:

  • New and draft FDA guidances;
  • Implications of new regulations
  • Reasons/causes for the most recent warning letters;
  • Updates on key regulatory developments;
  • Tips to prepare for FDA inspections;
  • Proven ways to improve design control procedures; and
  • Ideas to create more effective GMP training programs.

PLUS, you get links to key documents acquired by the FDAnews editorial staff, including actual 483s, warning letters, closeout letters, guidances, FDA notices, and many others.

BONUS:Renew your subscription NOW and save $150 off the regular one-year price of $997 — plus receive a FREE copy of our webinar CD, FDA’s New Generic Drug Safety Labeling Rule – a $347 value!

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with The GMP Letter, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to The GMP Letter today. It couldn’t be easier.

Monthly, 12 issues/year. Electronic Delivery

$885.00

483sOnline.com - Two-Year Unlimited Access Renewal W/CD

It’s no secret: Form 483s are the best resources available to understand what FDA investigators are looking for today. In fact, by referring to the observations in recently-issued 483s, you can:

  • Prepare your own facility to withstand the inspection scrutiny;
  • Assess your competitors’ compliance;
  • Background potential business partners’ compliance records;
  • Learn from the mistakes of others and better manage your own manufacturing operations; and
  • Create training and quality improvement scenarios based on real-life findings.

There’s only one catch about 483s. It isn’t very easy or cost-effective to get them from the FDA. First, there’s the expense of using staff time to make your FOIA request … then the cost of each 483 … and finally the long wait before they actually arrive.

But now there’s a new, better way to acquire 483s.

With a subscription to 483sOnline.com, you get round-the-clock, unlimited access to more than two thousand recent 483s ... with new ones being added weekly. Need to find what you are looking for in a hurry? You can search by:

  • Company name
  • Date of Inspection
  • Inspector Name
  • Region
  • Keyword

And the 483s are ready for you to download instantly.

You even get a weekly email notice of the new 483s we've added, so you're sure never to miss a thing.

This subscription is for single user only. Licenses for multiple users and/or multiple locations are also available at significant discounts. For more information, contact Nelly Valentin at nvalentin@fdanews.com or (888) 838-5578.

$1,795.00

483sOnline.com - One-Year Unlimited Access Renewal W/CD

It’s no secret: Form 483s are the best resources available to understand what FDA investigators are looking for today. In fact, by referring to the observations in recently-issued 483s, you can:

  • Prepare your own facility to withstand the inspection scrutiny;
  • Assess your competitors’ compliance;
  • Background potential business partners’ compliance records;
  • Learn from the mistakes of others and better manage your own manufacturing operations; and
  • Create training and quality improvement scenarios based on real-life findings.

There’s only one catch about 483s. It isn’t very easy or cost-effective to get them from the FDA. First, there’s the expense of using staff time to make your FOIA request … then the cost of each 483 … and finally the long wait before they actually arrive.

But now there’s a new, better way to acquire 483s.

With a subscription to 483sOnline.com, you get round-the-clock, unlimited access to more than two thousand recent 483s ... with new ones being added weekly. Need to find what you are looking for in a hurry? You can search by:

  • Company name
  • Date of Inspection
  • Inspector Name
  • Region
  • Keyword

And the 483s are ready for you to download instantly.

You even get a weekly email notice of the new 483s we've added, so you're sure never to miss a thing.

This subscription is for single user only. Licenses for multiple users and/or multiple locations are also available at significant discounts. For more information, contact Nelly Valentin at nvalentin@fdanews.com or (888) 838-5578.

$997.00

Drug GMP Report 2-Year Renewal W/Webinar CD

Drug GMP Report

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.

$1,791.00

Drug GMP Report 1-Year Renewal W/Webinar CD

Drug GMP Report

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.

$995.00

Drug Industry Daily 2-Year Renewal W/Management Report

Drug Industry Daily

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators ... and what their competitors are up to.

Don't waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID's experienced in-house editorial team do the work for you. Use your energy where it's needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

PLUS: in every issue, you get links to additional documents that support DID’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug Industry Daily, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug Industry Daily today. It couldn’t be easier.

$2,421.00

Drug Industry Daily 1-Year Renewal W/Management Report

Drug Industry Daily

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators ... and what their competitors are up to.

Don't waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID's experienced in-house editorial team do the work for you. Use your energy where it's needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

PLUS: in every issue, you get links to additional documents that support DID’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug Industry Daily, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug Industry Daily today. It couldn’t be easier.

$1,345.00

Webinar Training Pass 2-Year Renewal W/Management Report

 

We can’t give you more staff members or travel money to get to new training programs. But we can provide expert training for you in ONE place … without ever leaving your office.

FDAnews’ Webinar Training Pass

The Training Pass program gives you year-round unrestricted access to hundreds of web-based training programs, featuring top consultants, expert speakers and FDA officials.

Topics covered in these training webinars include social media, GLP Auditing, inspectional readiness, process validation, recalls, spreadsheet validation, Pharmacovigilance strategies, understanding biosimilars, insight on PDUFA V, adverse event compliance and reporting, QSR Data, supply chain risks, financial disclosure requirements for clinical investigators and much more.

When you register for the Training Pass, you get instant on-demand access to our ever growing collection of webinars, AND access to all of our LIVE webinars for the life of your subscription.

You’ll automatically be registered for every webinar we host — we'll send dial-in instructions via email prior to every webinar and a monthly reminder of upcoming programs. You’ll always have access to our archive programs. All you have to do is dial in!

That’s less than $11 for each archived webinar alone. Add in the live webinars you’ll have access to, during the year and the cost per training session drops even more.

To Recap, Here’s What Your New Training Pass Gives You:

  1. Training from the best minds and thought leaders in the industry.
  2. Wide variety of topics to help you stay in compliance with the FDA.
  3. Instant, on-demand, unlimited access to all 120+ archived webinars and 40 new ones we’re working on.
  4. One automatic registration to every live webinar we’ll ever host for the life of your subscription. You can get additional lines for half price.
  5. Special Training Pass member discounts to live workshops and conferences.

Get yours today!

Note: Your Training Pass allows you to have unlimited access to the archived webinars which can be viewed as many times as needed. You will also receive a registration for one dial-in to each live webinar over the life of your subscription.

$1,795.00

Webinar Training Pass 1-Year Renewal W/Management Report

 

We can’t give you more staff members or travel money to get to new training programs. But we can provide expert training for you in ONE place … without ever leaving your office.

FDAnews’ Webinar Training Pass

The Training Pass program gives you year-round unrestricted access to hundreds of web-based training programs, featuring top consultants, expert speakers and FDA officials.

Topics covered in these training webinars include social media, GLP Auditing, inspectional readiness, process validation, recalls, spreadsheet validation, Pharmacovigilance strategies, understanding biosimilars, insight on PDUFA V, adverse event compliance and reporting, QSR Data, supply chain risks, financial disclosure requirements for clinical investigators and much more.

When you register for the Training Pass, you get instant on-demand access to our ever growing collection of webinars, AND access to all of our LIVE webinars for the life of your subscription.

You’ll automatically be registered for every webinar we host — we'll send dial-in instructions via email prior to every webinar and a monthly reminder of upcoming programs. You’ll always have access to our archive programs. All you have to do is dial in!

That’s less than $11 for each archived webinar alone. Add in the live webinars you’ll have access to, during the year and the cost per training session drops even more.

To Recap, Here’s What Your New Training Pass Gives You:

  1. Training from the best minds and thought leaders in the industry.
  2. Wide variety of topics to help you stay in compliance with the FDA.
  3. Instant, on-demand, unlimited access to all 120+ archived webinars and 40 new ones we’re working on.
  4. One automatic registration to every live webinar we’ll ever host for the life of your subscription. You can get additional lines for half price.
  5. Special Training Pass member discounts to live workshops and conferences.

Get yours today!

Note: Your Training Pass allows you to have unlimited access to the archived webinars which can be viewed as many times as needed. You will also receive a registration for one dial-in to each live webinar over the life of your subscription.

$997.00

The GMP Letter 2-Year Renewal W/Free Webinar CD

The GMP Letter

The GMP Letter (GMP) to stay on top of the FDA's interpretation and enforcement of the quality systems regulation and to learn which changes they must make to stay in compliance. In each monthly issue, you get an update on key regulatory developments, tips on how to prepare for FDA inspections, proven ways to improve design control procedures, ideas to create more effective GMP training programs and more.

With a subscription to The GMP Letter, you’ll get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

Each issue provides:

  • New and draft FDA guidances;
  • Implications of new regulations
  • Reasons/causes for the most recent warning letters;
  • Updates on key regulatory developments;
  • Tips to prepare for FDA inspections;
  • Proven ways to improve design control procedures; and
  • Ideas to create more effective GMP training programs.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with The GMP Letter, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to The GMP Letter today. It couldn’t be easier.

$1,773.00

The GMP Letter 1-Year Renewal W/Free Webinar CD

The GMP Letter

The GMP Letter (GMP) to stay on top of the FDA's interpretation and enforcement of the quality systems regulation and to learn which changes they must make to stay in compliance. In each monthly issue, you get an update on key regulatory developments, tips on how to prepare for FDA inspections, proven ways to improve design control procedures, ideas to create more effective GMP training programs and more.

With a subscription to The GMP Letter, you’ll get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

Each issue provides:

  • New and draft FDA guidances;
  • Implications of new regulations
  • Reasons/causes for the most recent warning letters;
  • Updates on key regulatory developments;
  • Tips to prepare for FDA inspections;
  • Proven ways to improve design control procedures; and
  • Ideas to create more effective GMP training programs.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with The GMP Letter, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to The GMP Letter today. It couldn’t be easier.

$985.00

International Pharmaceutical Regulatory Monitor 2-Year Renewal W/Management Report

International Pharmaceutical Regulatory Monitor

International Pharmaceutical Regulatory Monitor (IPRM) keeps pharma professionals on top of key changes in pharmaceutical regulation around the world, covering rules and standards from the FDA, the European Medicines Agency, Health Canada, Australia's TGA, the International Conference on Harmonisation and other agencies in Europe, Japan and elsewhere.

PLUS: in every issue, you get links to additional documents from international agencies and commissions that support IPRM’s articles, such as draft and final guidances, regulations and amendments, rules, court decisions, guidelines, procedures, explanatory notes and more.

With your subscription you’ll also receive:

  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
  • Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
  • FDAnews Drug Daily Bulletin. This daily email alert brings you important FDA and international regulatory, legislative and business news in the pharmaceutical industry.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with International Pharmaceutical Regulatory Monitor, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to International Pharmaceutical Regulatory Monitor today. It couldn’t be easier.

$1,431.00

International Pharmaceutical Regulatory Monitor 1-Year Renewal W/Management Report

International Pharmaceutical Regulatory Monitor

International Pharmaceutical Regulatory Monitor (IPRM) keeps pharma professionals on top of key changes in pharmaceutical regulation around the world, covering rules and standards from the FDA, the European Medicines Agency, Health Canada, Australia's TGA, the International Conference on Harmonisation and other agencies in Europe, Japan and elsewhere.

PLUS: in every issue, you get links to additional documents from international agencies and commissions that support IPRM’s articles, such as draft and final guidances, regulations and amendments, rules, court decisions, guidelines, procedures, explanatory notes and more.

With your subscription you’ll also receive:

  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
  • Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
  • FDAnews Drug Daily Bulletin. This daily email alert brings you important FDA and international regulatory, legislative and business news in the pharmaceutical industry.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with International Pharmaceutical Regulatory Monitor, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to International Pharmaceutical Regulatory Monitor today. It couldn’t be easier.

$1,431.00

Webinar Training Pass 2-Year Renewal W/Management Report

 

We can’t give you more staff members or travel money to get to new training programs. But we can provide expert training for you in ONE place … without ever leaving your office.

FDAnews’ Webinar Training Pass

The Training Pass program gives you year-round unrestricted access to hundreds of web-based training programs, featuring top consultants, expert speakers and FDA officials.

Topics covered in these training webinars include social media, GLP Auditing, inspectional readiness, process validation, recalls, spreadsheet validation, Pharmacovigilance strategies, understanding biosimilars, insight on PDUFA V, adverse event compliance and reporting, QSR Data, supply chain risks, financial disclosure requirements for clinical investigators and much more.

When you register for the Training Pass, you get instant on-demand access to our ever growing collection of webinars, AND access to all of our LIVE webinars for the life of your subscription.

You’ll automatically be registered for every webinar we host — we'll send dial-in instructions via email prior to every webinar and a monthly reminder of upcoming programs. You’ll always have access to our archive programs. All you have to do is dial in!

That’s less than $11 for each archived webinar alone. Add in the live webinars you’ll have access to, during the year and the cost per training session drops even more.

To Recap, Here’s What Your New Training Pass Gives You:

  1. Training from the best minds and thought leaders in the industry.
  2. Wide variety of topics to help you stay in compliance with the FDA.
  3. Instant, on-demand, unlimited access to all 120+ archived webinars and 40 new ones we’re working on.
  4. One automatic registration to every live webinar we’ll ever host for the life of your subscription. You can get additional lines for half price.
  5. Special Training Pass member discounts to live workshops and conferences.

Get yours today!

Note: Your Training Pass allows you to have unlimited access to the archived webinars which can be viewed as many times as needed. You will also receive a registration for one dial-in to each live webinar over the life of your subscription.

$1,438.00

Webinar Training Pass 1-Year Renewal W/Management Report

 

We can’t give you more staff members or travel money to get to new training programs. But we can provide expert training for you in ONE place … without ever leaving your office.

FDAnews’ Webinar Training Pass

The Training Pass program gives you year-round unrestricted access to hundreds of web-based training programs, featuring top consultants, expert speakers and FDA officials.

Topics covered in these training webinars include social media, GLP Auditing, inspectional readiness, process validation, recalls, spreadsheet validation, Pharmacovigilance strategies, understanding biosimilars, insight on PDUFA V, adverse event compliance and reporting, QSR Data, supply chain risks, financial disclosure requirements for clinical investigators and much more.

When you register for the Training Pass, you get instant on-demand access to our ever growing collection of webinars, AND access to all of our LIVE webinars for the life of your subscription.

You’ll automatically be registered for every webinar we host — we'll send dial-in instructions via email prior to every webinar and a monthly reminder of upcoming programs. You’ll always have access to our archive programs. All you have to do is dial in!

That’s less than $11 for each archived webinar alone. Add in the live webinars you’ll have access to, during the year and the cost per training session drops even more.

To Recap, Here’s What Your New Training Pass Gives You:

  1. Training from the best minds and thought leaders in the industry.
  2. Wide variety of topics to help you stay in compliance with the FDA.
  3. Instant, on-demand, unlimited access to all 120+ archived webinars and 40 new ones we’re working on.
  4. One automatic registration to every live webinar we’ll ever host for the life of your subscription. You can get additional lines for half price.
  5. Special Training Pass member discounts to live workshops and conferences.

Get yours today!

Note: Your Training Pass allows you to have unlimited access to the archived webinars which can be viewed as many times as needed. You will also receive a registration for one dial-in to each live webinar over the life of your subscription.

$799.00

International Devices & Diagnostics Monitor Renewal W/MR

Product Description
$2,155.00

International Devices & Diagnostics Monitor Renewal/MR

Product Description
$1,197.00

International Devices & Diagnostics Monitor Renewal W/MR

Product Description
$1,438.00

International Devices & Diagnostics Monitor Renewal W/MR

Product Description
$799.00

Inspection Insider 2 Year Renewal W/Mgmt Report

Product Description
$1,795.00

Inspection Insider 1 Year Renewal W/Mgmt Report

Product Description
$997.00

Drug GMP Report 1-Year Renewal W/Webinar

Drug GMP Report

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.

$995.00

Drug GMP Report 2-Year Renewal W/Webinar

Drug GMP Report

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.

$1,791.00

Drug Industry Daily 1-Year Renewal W/Webinar

Drug Industry Daily

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators ... and what their competitors are up to.

Don't waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID's experienced in-house editorial team do the work for you. Use your energy where it's needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

PLUS: in every issue, you get links to additional documents that support DID’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug Industry Daily, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug Industry Daily today. It couldn’t be easier.

$1,345.00

Drug Industry Daily 2-Year Renewal W/Webinar

Drug Industry Daily

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators ... and what their competitors are up to.

Don't waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID's experienced in-house editorial team do the work for you. Use your energy where it's needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

PLUS: in every issue, you get links to additional documents that support DID’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug Industry Daily, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug Industry Daily today. It couldn’t be easier.

$2,421.00

International Devices & Diagnostics Monitor Renewal W/Webinar

Product Description
$1,197.00

International Devices & Diagnostics Monitor Renewal W/Webinar

Product Description
$2,155.00

International Devices & Diagnostics Monitor Renewal W/Webinar

Product Description
$799.00

International Devices & Diagnostics Monitor Renewal W/Webinar

Product Description
$1,438.00

International Pharmaceutical Regulatory Monitor 1-Year Renewal W/Webinar

International Pharmaceutical Regulatory Monitor

International Pharmaceutical Regulatory Monitor (IPRM) keeps pharma professionals on top of key changes in pharmaceutical regulation around the world, covering rules and standards from the FDA, the European Medicines Agency, Health Canada, Australia's TGA, the International Conference on Harmonisation and other agencies in Europe, Japan and elsewhere.

PLUS: in every issue, you get links to additional documents from international agencies and commissions that support IPRM’s articles, such as draft and final guidances, regulations and amendments, rules, court decisions, guidelines, procedures, explanatory notes and more.

With your subscription you’ll also receive:

  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
  • Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
  • FDAnews Drug Daily Bulletin. This daily email alert brings you important FDA and international regulatory, legislative and business news in the pharmaceutical industry.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with International Pharmaceutical Regulatory Monitor, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to International Pharmaceutical Regulatory Monitor today. It couldn’t be easier.

$1,431.00

International Pharmaceutical Regulatory Monitor 2-Year Renewal W/Webinar

International Pharmaceutical Regulatory Monitor

International Pharmaceutical Regulatory Monitor (IPRM) keeps pharma professionals on top of key changes in pharmaceutical regulation around the world, covering rules and standards from the FDA, the European Medicines Agency, Health Canada, Australia's TGA, the International Conference on Harmonisation and other agencies in Europe, Japan and elsewhere.

PLUS: in every issue, you get links to additional documents from international agencies and commissions that support IPRM’s articles, such as draft and final guidances, regulations and amendments, rules, court decisions, guidelines, procedures, explanatory notes and more.

With your subscription you’ll also receive:

  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
  • Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
  • FDAnews Drug Daily Bulletin. This daily email alert brings you important FDA and international regulatory, legislative and business news in the pharmaceutical industry.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with International Pharmaceutical Regulatory Monitor, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to International Pharmaceutical Regulatory Monitor today. It couldn’t be easier.

$1,431.00

Webinar Training Pass Subscription Discounted Price

 

We can’t provide you with more staff members or travel money to get to new training programs. But we can provide expert training for you in ONE place … without ever leaving your office.

Introducing FDAnews’ Webinar Training Pass

The Training Pass program gives you year-round unrestricted access to hundreds of web-based training programs, featuring top consultants, expert speakers and FDA officials.

Need training on a topic for your entire team? The Training Pass lets you train on your schedule – on the subjects you need most. Gather your entire team to view an archived webinar together OR let them view and listen on their own time.

Topics covered in these training webinars include social media, inspectional readiness, process validation, recalls, spreadsheet validation, Pharmacovigilance strategies, understanding biosimilars, insight on PDUFA V, adverse event compliance and reporting, QSR Data, supply chain risks and much more.

When you register for the Training Pass, you get instant on-demand access to our ever growing collection of webinars, AND access to all of our LIVE webinars for the life of your subscription.

You’ll automatically be registered for every webinar we host — we'll send dial-in instructions via email prior to every webinar and a monthly reminder of upcoming programs. You’ll always have access to our archive programs. All you have to do is dial in!

How Much Will Your New Training Pass Cost?

The Training Pass price is normally $1,297, but today you can get it for a LOW, introductory price of only $997. That’s a $300 savings!

That’s less than $10 for each archived webinar alone. Add in the live webinars you’ll have access to, during the year and the cost per training session drops even more.

Order yours now!

To Recap, Here’s What Your New Training Pass Gives You:

  1. Training from the best minds and thought leaders in the pharma, device and clinical industries.
  2. Wide variety of topics to help you stay in compliance with the FDA.
  3. Instant, on-demand unlimited access to all archived webinars for each member of your team.
  4. One automatic registration to every live webinar we’ll ever host for the life of your subscription. You can get additional lines for half price.
  5. Special Training Pass member discounts to live workshops and conferences.

Act now to purchase this limited time Training Pass offer, before our special promotional offer ends!

Get yours today!

Note: Your Training Pass allows you to have unlimited access to the archived and they can be viewed as many times as needed. You will receive a registration good for one dial-in to each live webinar over the life of your subscription.

$510.00

Drug GMP Report Subscription - Save $200 On a One-Year Subscription

Drug GMP Report

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.

$1,045.00
$845.00
$200.00 (19%)

Save $200 on One-Year Subscription to International Pharmaceutical Regulatory Monitor

International Pharmaceutical Regulatory Monitor

International Pharmaceutical Regulatory Monitor (IPRM) keeps pharma professionals on top of key changes in pharmaceutical regulation around the world, covering rules and standards from the FDA, the European Medicines Agency, Health Canada, Australia's TGA, the International Conference on Harmonisation and other agencies in Europe, Japan and elsewhere.

PLUS: in every issue, you get links to additional documents from international agencies and commissions that support IPRM’s articles, such as draft and final guidances, regulations and amendments, rules, court decisions, guidelines, procedures, explanatory notes and more.

With your subscription you’ll also receive:

  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
  • Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
  • FDAnews Drug Daily Bulletin. This daily email alert brings you important FDA and international regulatory, legislative and business news in the pharmaceutical industry.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with International Pharmaceutical Regulatory Monitor, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to International Pharmaceutical Regulatory Monitor today. It couldn’t be easier.

$695.00

Webinar Training Pass 1-Year Renewal W/Management Report

 

We can’t give you more staff members or travel money to get to new training programs. But we can provide expert training for you in ONE place … without ever leaving your office.

FDAnews’ Webinar Training Pass

The Training Pass program gives you year-round unrestricted access to hundreds of web-based training programs, featuring top consultants, expert speakers and FDA officials.

Topics covered in these training webinars include social media, GLP Auditing, inspectional readiness, process validation, recalls, spreadsheet validation, Pharmacovigilance strategies, understanding biosimilars, insight on PDUFA V, adverse event compliance and reporting, QSR Data, supply chain risks, financial disclosure requirements for clinical investigators and much more.

When you register for the Training Pass, you get instant on-demand access to our ever growing collection of webinars, AND access to all of our LIVE webinars for the life of your subscription.

You’ll automatically be registered for every webinar we host — we'll send dial-in instructions via email prior to every webinar and a monthly reminder of upcoming programs. You’ll always have access to our archive programs. All you have to do is dial in!

That’s less than $11 for each archived webinar alone. Add in the live webinars you’ll have access to, during the year and the cost per training session drops even more.

To Recap, Here’s What Your New Training Pass Gives You:

  1. Training from the best minds and thought leaders in the industry.
  2. Wide variety of topics to help you stay in compliance with the FDA.
  3. Instant, on-demand, unlimited access to all 120+ archived webinars and 40 new ones we’re working on.
  4. One automatic registration to every live webinar we’ll ever host for the life of your subscription. You can get additional lines for half price.
  5. Special Training Pass member discounts to live workshops and conferences.

Get yours today!

Note: Your Training Pass allows you to have unlimited access to the archived webinars which can be viewed as many times as needed. You will also receive a registration for one dial-in to each live webinar over the life of your subscription.

$697.00

Drug GMP Report 1-Year Renewal

Drug GMP Report

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.

$645.00

The GMP Letter 1-Year Renewal

The GMP Letter

The GMP Letter (GMP) to stay on top of the FDA's interpretation and enforcement of the quality systems regulation and to learn which changes they must make to stay in compliance. In each monthly issue, you get an update on key regulatory developments, tips on how to prepare for FDA inspections, proven ways to improve design control procedures, ideas to create more effective GMP training programs and more.

With a subscription to The GMP Letter, you’ll get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

Each issue provides:

  • New and draft FDA guidances;
  • Implications of new regulations
  • Reasons/causes for the most recent warning letters;
  • Updates on key regulatory developments;
  • Tips to prepare for FDA inspections;
  • Proven ways to improve design control procedures; and
  • Ideas to create more effective GMP training programs.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with The GMP Letter, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to The GMP Letter today. It couldn’t be easier.

$685.00

International Pharmaceutical Regulatory Monitor 1-Year Renewal

International Pharmaceutical Regulatory Monitor

International Pharmaceutical Regulatory Monitor (IPRM) keeps pharma professionals on top of key changes in pharmaceutical regulation around the world, covering rules and standards from the FDA, the European Medicines Agency, Health Canada, Australia's TGA, the International Conference on Harmonisation and other agencies in Europe, Japan and elsewhere.

PLUS: in every issue, you get links to additional documents from international agencies and commissions that support IPRM’s articles, such as draft and final guidances, regulations and amendments, rules, court decisions, guidelines, procedures, explanatory notes and more.

With your subscription you’ll also receive:

  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
  • Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
  • FDAnews Drug Daily Bulletin. This daily email alert brings you important FDA and international regulatory, legislative and business news in the pharmaceutical industry.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with International Pharmaceutical Regulatory Monitor, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to International Pharmaceutical Regulatory Monitor today. It couldn’t be easier.

$495.00

483sOnline.com - One-Year Unlimited Access Renewal

It’s no secret: Form 483s are the best resources available to understand what FDA investigators are looking for today. In fact, by referring to the observations in recently-issued 483s, you can:

  • Prepare your own facility to withstand the inspection scrutiny;
  • Assess your competitors’ compliance;
  • Background potential business partners’ compliance records;
  • Learn from the mistakes of others and better manage your own manufacturing operations; and
  • Create training and quality improvement scenarios based on real-life findings.

There’s only one catch about 483s. It isn’t very easy or cost-effective to get them from the FDA. First, there’s the expense of using staff time to make your FOIA request … then the cost of each 483 … and finally the long wait before they actually arrive.

But now there’s a new, better way to acquire 483s.

With a subscription to 483sOnline.com, you get round-the-clock, unlimited access to more than two thousand recent 483s ... with new ones being added weekly. Need to find what you are looking for in a hurry? You can search by:

  • Company name
  • Date of Inspection
  • Inspector Name
  • Region
  • Keyword

And the 483s are ready for you to download instantly.

You even get a weekly email notice of the new 483s we've added, so you're sure never to miss a thing.

This subscription is for single user only. Licenses for multiple users and/or multiple locations are also available at significant discounts. For more information, contact Nelly Valentin at nvalentin@fdanews.com or (888) 838-5578.

$697.00

Drug Industry Daily 1-Year Renewal

Drug Industry Daily

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators ... and what their competitors are up to.

Don't waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID's experienced in-house editorial team do the work for you. Use your energy where it's needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

PLUS: in every issue, you get links to additional documents that support DID’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug Industry Daily, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug Industry Daily today. It couldn’t be easier.

$847.00

The GMP Letter - Save $200 On a One-Year Subscription

The GMP Letter

The GMP Letter (GMP) is your key to staying on top of the FDA's interpretation and enforcement of the quality systems regulation and to learn which changes they must make to stay in compliance. In each monthly issue, you get an update on key regulatory developments, tips on how to prepare for FDA inspections, proven ways to improve design control procedures, ideas to create more effective GMP training programs and more.

With a subscription to The GMP Letter, you’ll get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

Each issue provides:

  • New and draft FDA guidances;
  • Implications of new regulations
  • Reasons/causes for the most recent warning letters;
  • Updates on key regulatory developments;
  • Tips to prepare for FDA inspections;
  • Proven ways to improve design control procedures; and
  • Ideas to create more effective GMP training programs.

PLUS, you get links to key documents acquired by the FDAnews editorial staff, including actual 483s, warning letters, closeout letters, guidances, FDA notices, and many others.

BONUS:Renew your subscription NOW and save $150 off the regular one-year price of $997 — plus receive a FREE copy of our webinar CD, FDA’s New Generic Drug Safety Labeling Rule – a $347 value!

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with The GMP Letter, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to The GMP Letter today. It couldn’t be easier.

Monthly, 12 issues/year. Electronic Delivery

$885.00

Inspection Insider 1 Year Renewal W/DVD and MR

Product Description
$697.00

50% Off One-Year Subscription to Drug Industry Daily

Drug Industry Daily

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators ... and what their competitors are up to.

Don't waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID's experienced in-house editorial team do the work for you. Use your energy where it's needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

PLUS: in every issue, you get links to additional documents that support DID’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug Industry Daily, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug Industry Daily today. It couldn’t be easier.

$847.00

Drug GMP Report Subscription - Save $200 On a One-Year Subscription

Drug GMP Report

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.

$845.00

The GMP Letter - Save $200 On a One-Year Subscription

The GMP Letter

The GMP Letter (GMP) is your key to staying on top of the FDA's interpretation and enforcement of the quality systems regulation and to learn which changes they must make to stay in compliance. In each monthly issue, you get an update on key regulatory developments, tips on how to prepare for FDA inspections, proven ways to improve design control procedures, ideas to create more effective GMP training programs and more.

With a subscription to The GMP Letter, you’ll get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

Each issue provides:

  • New and draft FDA guidances;
  • Implications of new regulations
  • Reasons/causes for the most recent warning letters;
  • Updates on key regulatory developments;
  • Tips to prepare for FDA inspections;
  • Proven ways to improve design control procedures; and
  • Ideas to create more effective GMP training programs.

PLUS, you get links to key documents acquired by the FDAnews editorial staff, including actual 483s, warning letters, closeout letters, guidances, FDA notices, and many others.

BONUS:Renew your subscription NOW and save $150 off the regular one-year price of $997 — plus receive a FREE copy of our webinar CD, FDA’s New Generic Drug Safety Labeling Rule – a $347 value!

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with The GMP Letter, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to The GMP Letter today. It couldn’t be easier.

Monthly, 12 issues/year. Electronic Delivery

$885.00

The GMP Letter - Save $200 On a One-Year Subscription

The GMP Letter

The GMP Letter (GMP) is your key to staying on top of the FDA's interpretation and enforcement of the quality systems regulation and to learn which changes they must make to stay in compliance. In each monthly issue, you get an update on key regulatory developments, tips on how to prepare for FDA inspections, proven ways to improve design control procedures, ideas to create more effective GMP training programs and more.

With a subscription to The GMP Letter, you’ll get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

Each issue provides:

  • New and draft FDA guidances;
  • Implications of new regulations
  • Reasons/causes for the most recent warning letters;
  • Updates on key regulatory developments;
  • Tips to prepare for FDA inspections;
  • Proven ways to improve design control procedures; and
  • Ideas to create more effective GMP training programs.

PLUS, you get links to key documents acquired by the FDAnews editorial staff, including actual 483s, warning letters, closeout letters, guidances, FDA notices, and many others.

BONUS:Renew your subscription NOW and save $150 off the regular one-year price of $997 — plus receive a FREE copy of our webinar CD, FDA’s New Generic Drug Safety Labeling Rule – a $347 value!

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with The GMP Letter, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to The GMP Letter today. It couldn’t be easier.

Monthly, 12 issues/year. Electronic Delivery

$885.00

International Devices & Diagnostics Monitor - Save $300 on a One-Year Subscription

International Devices & Diagnostics Monitor
Product Description
$947.00

Save $200 on One-Year Subscription to International Pharmaceutical Regulatory Monitor

International Pharmaceutical Regulatory Monitor

International Pharmaceutical Regulatory Monitor (IPRM) keeps pharma professionals on top of key changes in pharmaceutical regulation around the world, covering rules and standards from the FDA, the European Medicines Agency, Health Canada, Australia's TGA, the International Conference on Harmonisation and other agencies in Europe, Japan and elsewhere.

PLUS: in every issue, you get links to additional documents from international agencies and commissions that support IPRM’s articles, such as draft and final guidances, regulations and amendments, rules, court decisions, guidelines, procedures, explanatory notes and more.

With your subscription you’ll also receive:

  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
  • Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
  • FDAnews Drug Daily Bulletin. This daily email alert brings you important FDA and international regulatory, legislative and business news in the pharmaceutical industry.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with International Pharmaceutical Regulatory Monitor, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to International Pharmaceutical Regulatory Monitor today. It couldn’t be easier.

$695.00

Webinar Training Pass Subscription

 

We can’t provide you with more staff members or travel money to get to new training programs. But we can provide expert training for you in ONE place … without ever leaving your office.

Introducing FDAnews’ Webinar Training Pass

The Training Pass program gives you year-round unrestricted access to hundreds of web-based training programs, featuring top consultants, expert speakers and FDA officials.

Need training on a topic for your entire team? The Training Pass lets you train on your schedule – on the subjects you need most. Gather your entire team to view an archived webinar together OR let them view and listen on their own time.

Topics covered in these training webinars include social media, inspectional readiness, process validation, recalls, spreadsheet validation, Pharmacovigilance strategies, understanding biosimilars, insight on PDUFA V, adverse event compliance and reporting, QSR Data, supply chain risks and much more.

When you register for the Training Pass, you get instant on-demand access to our ever growing collection of webinars, AND access to all of our LIVE webinars for the life of your subscription.

You’ll automatically be registered for every webinar we host — we'll send dial-in instructions via email prior to every webinar and a monthly reminder of upcoming programs. You’ll always have access to our archive programs. All you have to do is dial in!

How Much Will Your New Training Pass Cost?

The Training Pass price is normally $1,297, but today you can get it for a LOW, introductory price of only $797. That’s a $500 savings!

That’s less than $10 for each archived webinar alone. Add in the live webinars you’ll have access to, during the year and the cost per training session drops even more.

Order yours now!

To Recap, Here’s What Your New Training Pass Gives You:

  1. Training from the best minds and thought leaders in the pharma, device and clinical industries.
  2. Wide variety of topics to help you stay in compliance with the FDA.
  3. Instant, on-demand unlimited access to all archived webinars for each member of your team.
  4. One automatic registration to every live webinar we’ll ever host for the life of your subscription. You can get additional lines for half price.
  5. Special Training Pass member discounts to live workshops and conferences.

Act now to purchase this limited time Training Pass offer, before our special promotional offer ends!

Get yours today!

Note: Your Training Pass allows you to have unlimited access to the archived and they can be viewed as many times as needed. You will receive a registration good for one dial-in to each live webinar over the life of your subscription.

$797.00

FDAnews' 483s Online Membership

Product Description
$797.00

Webinar Training Pass Renewal

 

We can’t give you more staff members or travel money to get to new training programs. But we can provide expert training for you in ONE place … without ever leaving your office.

FDAnews’ Webinar Training Pass

The Training Pass program gives you year-round unrestricted access to hundreds of web-based training programs, featuring top consultants, expert speakers and FDA officials.

Topics covered in these training webinars include social media, GLP Auditing, inspectional readiness, process validation, recalls, spreadsheet validation, Pharmacovigilance strategies, understanding biosimilars, insight on PDUFA V, adverse event compliance and reporting, QSR Data, supply chain risks, financial disclosure requirements for clinical investigators and much more.

When you register for the Training Pass, you get instant on-demand access to our ever growing collection of webinars, AND access to all of our LIVE webinars for the life of your subscription.

You’ll automatically be registered for every webinar we host — we'll send dial-in instructions via email prior to every webinar and a monthly reminder of upcoming programs. You’ll always have access to our archive programs. All you have to do is dial in!

That’s less than $11 for each archived webinar alone. Add in the live webinars you’ll have access to, during the year and the cost per training session drops even more.

To Recap, Here’s What Your New Training Pass Gives You:

  1. Training from the best minds and thought leaders in the industry.
  2. Wide variety of topics to help you stay in compliance with the FDA.
  3. Instant, on-demand, unlimited access to all 120+ archived webinars and 40 new ones we’re working on.
  4. One automatic registration to every live webinar we’ll ever host for the life of your subscription. You can get additional lines for half price.
  5. Special Training Pass member discounts to live workshops and conferences.

Get yours today!

Note: Your Training Pass allows you to have unlimited access to the archived webinars which can be viewed as many times as needed. You will also receive a registration for one dial-in to each live webinar over the life of your subscription.

$997.00

Drug Industry Daily 1-Year Subscription

Drug Industry Daily

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators ... and what their competitors are up to.

Don't waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID's experienced in-house editorial team do the work for you. Use your energy where it's needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

PLUS: in every issue, you get links to additional documents that support DID’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug Industry Daily, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug Industry Daily today. It couldn’t be easier.

$847.00

FDAnews' 483s Online Membership

Product Description
$1,297.00

483sOnline.com - One-Year Unlimited Access Subscription w/Free ebook: Effective 483 Responses

483sOnline.com is your own personal pre-investigation intelligence tool that identifies exactly what investigators are focusing on before they show up.

483sOnline.com is more than just a library of 3,100 Form 483s.  It’s a tool you can use every day to help stay in compliance with FDA regulations. You can search:

  • By keyword or phrase: Search through all observations for each 483 — by the exact keyword or phrase you’re looking for, giving you the intelligence you need;
  • By date: Find out what issues the investigators have focused on in the recent past;

  • By company: Find out how things are going at companies just like yours;
     
  • By investigator name: Learn about the investigating trends of the official that’s likely to conduct your next inspection.

 

And the 483s are ready for you to download instantly.

You even get a weekly email notice of the new 483s we've added, so you're sure never to miss a thing.

This subscription offer is for one user only, but you're eligible for a significant discount on a multi-user and/or multi-location license. Get your entire company or department involved in scouring 483s for information that can help you with FDA inspections. For more information, contact us at (888) 838-5578.

$797.00

483sOnline.com - 2-Year Unlimited Access Renewal w/ eBook

Missing Description
$1,676.00

483sOnline.com - 1-Year Unlimited Access Renewal w eBook

It’s no secret: Form 483s are the best resources available to understand what FDA investigators are looking for today. In fact, by referring to the observations in recently-issued 483s, you can:

  • Prepare your own facility to withstand the inspection scrutiny;
  • Assess your competitors’ compliance;
  • Background potential business partners’ compliance records;
  • Learn from the mistakes of others and better manage your own manufacturing operations; and
  • Create training and quality improvement scenarios based on real-life findings.

There’s only one catch about 483s. It isn’t very easy or cost-effective to get them from the FDA. First, there’s the expense of using staff time to make your FOIA request … then the cost of each 483 … and finally the long wait before they actually arrive.

But now there’s a new, better way to acquire 483s.

With a subscription to 483sOnline.com, you get round-the-clock, unlimited access to more than two thousand recent 483s ... with new ones being added weekly. Need to find what you are looking for in a hurry? You can search by:

  • Company name
  • Date of Inspection
  • Inspector Name
  • Region
  • Keyword

And the 483s are ready for you to download instantly.

You even get a weekly email notice of the new 483s we've added, so you're sure never to miss a thing.

This subscription is for single user only. Licenses for multiple users and/or multiple locations are also available at significant discounts. For more information, contact Nelly Valentin at nvalentin@fdanews.com or (888) 838-5578.

$973.00

FDAnews Online Books Library - 1-Year Renewal w/ Webinar

Product Description
$747.00

FDAnews Online Books Library - 2-Year Renewal w/ Webinar

Product Description
$1,346.00

Webinar Training Pass 2-Year Renewal w/ eBook

 

We can’t give you more staff members or travel money to get to new training programs. But we can provide expert training for you in ONE place … without ever leaving your office.

FDAnews’ Webinar Training Pass

The Training Pass program gives you year-round unrestricted access to hundreds of web-based training programs, featuring top consultants, expert speakers and FDA officials.

Topics covered in these training webinars include social media, GLP Auditing, inspectional readiness, process validation, recalls, spreadsheet validation, Pharmacovigilance strategies, understanding biosimilars, insight on PDUFA V, adverse event compliance and reporting, QSR Data, supply chain risks, financial disclosure requirements for clinical investigators and much more.

When you register for the Training Pass, you get instant on-demand access to our ever growing collection of webinars, AND access to all of our LIVE webinars for the life of your subscription.

You’ll automatically be registered for every webinar we host — we'll send dial-in instructions via email prior to every webinar and a monthly reminder of upcoming programs. You’ll always have access to our archive programs. All you have to do is dial in!

That’s less than $11 for each archived webinar alone. Add in the live webinars you’ll have access to, during the year and the cost per training session drops even more.

To Recap, Here’s What Your New Training Pass Gives You:

  1. Training from the best minds and thought leaders in the industry.
  2. Wide variety of topics to help you stay in compliance with the FDA.
  3. Instant, on-demand, unlimited access to all 120+ archived webinars and 40 new ones we’re working on.
  4. One automatic registration to every live webinar we’ll ever host for the life of your subscription. You can get additional lines for half price.
  5. Special Training Pass member discounts to live workshops and conferences.

Get yours today!

Note: Your Training Pass allows you to have unlimited access to the archived webinars which can be viewed as many times as needed. You will also receive a registration for one dial-in to each live webinar over the life of your subscription.

$1,346.00

Webinar Training Pass 1-Year Renewal w/ eBook

 

We can’t give you more staff members or travel money to get to new training programs. But we can provide expert training for you in ONE place … without ever leaving your office.

FDAnews’ Webinar Training Pass

The Training Pass program gives you year-round unrestricted access to hundreds of web-based training programs, featuring top consultants, expert speakers and FDA officials.

Topics covered in these training webinars include social media, GLP Auditing, inspectional readiness, process validation, recalls, spreadsheet validation, Pharmacovigilance strategies, understanding biosimilars, insight on PDUFA V, adverse event compliance and reporting, QSR Data, supply chain risks, financial disclosure requirements for clinical investigators and much more.

When you register for the Training Pass, you get instant on-demand access to our ever growing collection of webinars, AND access to all of our LIVE webinars for the life of your subscription.

You’ll automatically be registered for every webinar we host — we'll send dial-in instructions via email prior to every webinar and a monthly reminder of upcoming programs. You’ll always have access to our archive programs. All you have to do is dial in!

That’s less than $11 for each archived webinar alone. Add in the live webinars you’ll have access to, during the year and the cost per training session drops even more.

To Recap, Here’s What Your New Training Pass Gives You:

  1. Training from the best minds and thought leaders in the industry.
  2. Wide variety of topics to help you stay in compliance with the FDA.
  3. Instant, on-demand, unlimited access to all 120+ archived webinars and 40 new ones we’re working on.
  4. One automatic registration to every live webinar we’ll ever host for the life of your subscription. You can get additional lines for half price.
  5. Special Training Pass member discounts to live workshops and conferences.

Get yours today!

Note: Your Training Pass allows you to have unlimited access to the archived webinars which can be viewed as many times as needed. You will also receive a registration for one dial-in to each live webinar over the life of your subscription.

$747.00

Webinar Training Pass 1-Year Renewal w/ eBook

 

We can’t give you more staff members or travel money to get to new training programs. But we can provide expert training for you in ONE place … without ever leaving your office.

FDAnews’ Webinar Training Pass

The Training Pass program gives you year-round unrestricted access to hundreds of web-based training programs, featuring top consultants, expert speakers and FDA officials.

Topics covered in these training webinars include social media, GLP Auditing, inspectional readiness, process validation, recalls, spreadsheet validation, Pharmacovigilance strategies, understanding biosimilars, insight on PDUFA V, adverse event compliance and reporting, QSR Data, supply chain risks, financial disclosure requirements for clinical investigators and much more.

When you register for the Training Pass, you get instant on-demand access to our ever growing collection of webinars, AND access to all of our LIVE webinars for the life of your subscription.

You’ll automatically be registered for every webinar we host — we'll send dial-in instructions via email prior to every webinar and a monthly reminder of upcoming programs. You’ll always have access to our archive programs. All you have to do is dial in!

That’s less than $11 for each archived webinar alone. Add in the live webinars you’ll have access to, during the year and the cost per training session drops even more.

To Recap, Here’s What Your New Training Pass Gives You:

  1. Training from the best minds and thought leaders in the industry.
  2. Wide variety of topics to help you stay in compliance with the FDA.
  3. Instant, on-demand, unlimited access to all 120+ archived webinars and 40 new ones we’re working on.
  4. One automatic registration to every live webinar we’ll ever host for the life of your subscription. You can get additional lines for half price.
  5. Special Training Pass member discounts to live workshops and conferences.

Get yours today!

Note: Your Training Pass allows you to have unlimited access to the archived webinars which can be viewed as many times as needed. You will also receive a registration for one dial-in to each live webinar over the life of your subscription.

$973.00

Webinar Training Pass 2-Year Renewal w/ eBook

 

We can’t give you more staff members or travel money to get to new training programs. But we can provide expert training for you in ONE place … without ever leaving your office.

FDAnews’ Webinar Training Pass

The Training Pass program gives you year-round unrestricted access to hundreds of web-based training programs, featuring top consultants, expert speakers and FDA officials.

Topics covered in these training webinars include social media, GLP Auditing, inspectional readiness, process validation, recalls, spreadsheet validation, Pharmacovigilance strategies, understanding biosimilars, insight on PDUFA V, adverse event compliance and reporting, QSR Data, supply chain risks, financial disclosure requirements for clinical investigators and much more.

When you register for the Training Pass, you get instant on-demand access to our ever growing collection of webinars, AND access to all of our LIVE webinars for the life of your subscription.

You’ll automatically be registered for every webinar we host — we'll send dial-in instructions via email prior to every webinar and a monthly reminder of upcoming programs. You’ll always have access to our archive programs. All you have to do is dial in!

That’s less than $11 for each archived webinar alone. Add in the live webinars you’ll have access to, during the year and the cost per training session drops even more.

To Recap, Here’s What Your New Training Pass Gives You:

  1. Training from the best minds and thought leaders in the industry.
  2. Wide variety of topics to help you stay in compliance with the FDA.
  3. Instant, on-demand, unlimited access to all 120+ archived webinars and 40 new ones we’re working on.
  4. One automatic registration to every live webinar we’ll ever host for the life of your subscription. You can get additional lines for half price.
  5. Special Training Pass member discounts to live workshops and conferences.

Get yours today!

Note: Your Training Pass allows you to have unlimited access to the archived webinars which can be viewed as many times as needed. You will also receive a registration for one dial-in to each live webinar over the life of your subscription.

$1,676.00

International Pharmaceutical Regulatory Monitor 2-Year Renewal W/Webinar

International Pharmaceutical Regulatory Monitor (IPRM) keeps pharma professionals on top of key changes in pharmaceutical regulation around the world, covering rules and standards from the FDA, the European Medicines Agency, Health Canada, Australia's TGA, the International Conference on Harmonisation and other agencies in Europe, Japan and elsewhere.

PLUS: in every issue, you get links to additional documents from international agencies and commissions that support IPRM’s articles, such as draft and final guidances, regulations and amendments, rules, court decisions, guidelines, procedures, explanatory notes and more.

With your subscription you’ll also receive:

  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
  • Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
  • FDAnews Drug Daily Bulletin. This daily email alert brings you important FDA and international regulatory, legislative and business news in the pharmaceutical industry.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with International Pharmaceutical Regulatory Monitor, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to International Pharmaceutical Regulatory Monitor today. It couldn’t be easier.

$1,209.00

International Pharmaceutical Regulatory Monitor 1-Year Renewal W/Webinar

International Pharmaceutical Regulatory Monitor (IPRM) keeps pharma professionals on top of key changes in pharmaceutical regulation around the world, covering rules and standards from the FDA, the European Medicines Agency, Health Canada, Australia's TGA, the International Conference on Harmonisation and other agencies in Europe, Japan and elsewhere.

PLUS: in every issue, you get links to additional documents from international agencies and commissions that support IPRM’s articles, such as draft and final guidances, regulations and amendments, rules, court decisions, guidelines, procedures, explanatory notes and more.

With your subscription you’ll also receive:

  • Email Alerts. Each electronic issue will be delivered right to your email inbox;
  • Online Access. Search the current issue, plus 8 years of archives by keyword and relevancy;
  • Free Documents. Each issue contains up to 10 links to full text of hard-to-obtain key int’l medical device regulatory references, guidances, consensus standards and industry reports, and other primary source documents you need. Never waste time tracking documents again!
  • FDAnews Drug Daily Bulletin. This daily email alert brings you important FDA and international regulatory, legislative and business news in the pharmaceutical industry.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with International Pharmaceutical Regulatory Monitor, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to International Pharmaceutical Regulatory Monitor today. It couldn’t be easier.

$671.00

International Devices & Diagnostics Monitor Renewal W/eBook

Product Description
$1,683.00

International Devices & Diagnostics Monitor 1-Yr. Renewal W/eBook

Product Description
$935.00

Drug Industry Daily 2-Year Renewal W/Webinar

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators ... and what their competitors are up to.

Don't waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID's experienced in-house editorial team do the work for you. Use your energy where it's needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

PLUS: in every issue, you get links to additional documents that support DID’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug Industry Daily, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug Industry Daily today. It couldn’t be easier.

$2,221.00

Drug Industry Daily 1-Year Renewal W/Webinar

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators ... and what their competitors are up to.

Don't waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID's experienced in-house editorial team do the work for you. Use your energy where it's needed most — ensuring that your products are in compliance and getting to market as quickly as possible.

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

PLUS: in every issue, you get links to additional documents that support DID’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug Industry Daily, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug Industry Daily today. It couldn’t be easier.

$1,233.00

The GMP Letter 2-Year Renewal W/Free eBook

The GMP Letter (GMP) to stay on top of the FDA's interpretation and enforcement of the quality systems regulation and to learn which changes they must make to stay in compliance. In each monthly issue, you get an update on key regulatory developments, tips on how to prepare for FDA inspections, proven ways to improve design control procedures, ideas to create more effective GMP training programs and more.

With a subscription to The GMP Letter, you’ll get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

Each issue provides:

  • New and draft FDA guidances;
  • Implications of new regulations
  • Reasons/causes for the most recent warning letters;
  • Updates on key regulatory developments;
  • Tips to prepare for FDA inspections;
  • Proven ways to improve design control procedures; and
  • Ideas to create more effective GMP training programs.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with The GMP Letter, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to The GMP Letter today. It couldn’t be easier.

$1,465.00

The GMP Letter 1-Year Renewal W/Free eBook

The GMP Letter (GMP) to stay on top of the FDA's interpretation and enforcement of the quality systems regulation and to learn which changes they must make to stay in compliance. In each monthly issue, you get an update on key regulatory developments, tips on how to prepare for FDA inspections, proven ways to improve design control procedures, ideas to create more effective GMP training programs and more.

With a subscription to The GMP Letter, you’ll get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

Each issue provides:

  • New and draft FDA guidances;
  • Implications of new regulations
  • Reasons/causes for the most recent warning letters;
  • Updates on key regulatory developments;
  • Tips to prepare for FDA inspections;
  • Proven ways to improve design control procedures; and
  • Ideas to create more effective GMP training programs.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with The GMP Letter, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to The GMP Letter today. It couldn’t be easier.

$813.00

Drug GMP Report 2-Year Renewal W/ Free eBook

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.

$1,411.00

Drug GMP Report 1-Year Renewal W/ Free eBook

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.

$783.00

Drug GMP Report 1-Year Print Renewal W/ Free eBook

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.

$803.00

Drug GMP Report 2-Year Print Renewal W/ Free eBook

A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.

PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.

There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.

So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.

$1,449.00

Clinical Trials Webinar Training Pass Subscription

GET ON-DEMAND CLINICAL TRIALS TRAINING
Gain Access to Dozens of Web-Based
Training Programs For One Low Price!

We can’t provide you with more staff members or travel money to get to new training programs. But we can provide expert training for you in ONE place … without ever leaving your office. The Webinar Training Pass gives you year-round unrestricted access to dozens of on-demand training webinars, featuring top clinical trials experts and FDA officials.

Need training on a topic? The Training Pass lets you train on your schedule — on the subjects you need most.

Webinar Training Pass Gives You:

  1. Training from the best minds and thought leaders in the clinical trials industry.

  2. Wide variety of topics to help you stay in compliance with the FDA.

  3. Instant, on-demand, unlimited access to dozens of archived webinars.

  4. One automatic registration to more than 60 live webinars we’ll host during the life of your subscription.

  5. A weekly email alert letting you know what webinars are coming up along with access links so you don't miss a thing!

Single-User, One-Year Unlimited
Webinar Access for only $597

Don’t forget this includes all our archives, PLUS all the new webinars we produce for 12 months, all available on YOUR SCHEDULE!

$797$597

 

Want training for your entire team? Call (888) 838-5578 or email customerservice@fdanews.com for multi-user pricing to receive deep discounts for 2, 5 or even unlimited users.

 

$597.00

483sOnline.com - One-Year Unlimited Access Subscription w/Free ebook: Managing Data and Documentation for FDA Inspections

483sOnline.com is your own personal pre-investigation intelligence tool that identifies exactly what investigators are focusing on before they show up.

483sOnline.com is more than just a library of 3,100 Form 483s.  It’s a tool you can use every day to help stay in compliance with FDA regulations. You can search:

  • By keyword or phrase: Search through all observations for each 483 — by the exact keyword or phrase you’re looking for, giving you the intelligence you need;
  • By date: Find out what issues the investigators have focused on in the recent past;

  • By company: Find out how things are going at companies just like yours;
     
  • By investigator name: Learn about the investigating trends of the official that’s likely to conduct your next inspection.

 

And the 483s are ready for you to download instantly.

You even get a weekly email notice of the new 483s we've added, so you're sure never to miss a thing.

This subscription offer is for one user only, but you're eligible for a significant discount on a multi-user and/or multi-location license. Get your entire company or department involved in scouring 483s for information that can help you with FDA inspections. For more information, contact us at (888) 838-5578.

$797.00

International Devices & Diagnostics Monitor 1 Year Subscription

Product Description
$847.00