Webinar Passport

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Your Training Pass gives you on-demand access to any of the webinars listed below. Scroll down to view the list in date order or click on one of the categories above to narrow your search. 

Getting started is easy...simply identify the webinar you want to watch, click on the "View Now" button and follow the instructions to start viewing.



Responding to Clinical Trial Inspectional Observations and FDA 483s (42 minutes)
Speaker: Dr. Darshan Kulkarni, Principal Attorney, Kulkarni Law Firm
Description: The more you know about how to handle 483s, the more power you have to handle things without facing subsequent warning letters, consent decrees … and terminated trials. In this webinar, you will learn strategic insights plus industry trends, case studies and ready-to-use advice including: latest areas of enforcement action trends with a focus on clinical trials, discussion of what’s triggering warning letters and consent decrees, deciding how to respond to an enforcement action, and much more.


How Not to Ruin a Perfectly Good Product With a Flawed Study Design (1 hour 3 minutes)
Speaker: Dr. Debbie Wilkerson, Clinical Research Director, Medtronic Spinal
Description: 58% of Phase III trials fail. Why? Sometimes it’s because the product is ineffective.  But more often than not it’s because of poor study design or implementation. Nearly every day, the newswires burn up with articles about high-profile products that are scrapped by their sponsors. Join Dr. Debbie Wilkerson for a presentation guiding you through examples of recognized study design guidances and best practices from correct and incorrect drug and device case studies.

Creating, Staffing and Managing an Inspection War Room (54 minutes)
Speaker: Dr. Darshan Kulkarni, Principal Attorney, Kulkarni Law Firm
Description: We’ve all heard the basic “How to Prepare for an Inspection” presentation. And we’ve heard your cries of “more detailed presentations, more specifics” on how to manage inspections. On Thursday, Nov. 8, FDAnews presented one of the year’s most anticipated — and detailed — webinars on inspectional preparedness. And now you can listen with this special encore presentation.

FDA-adopted Columbia-Suicide Severity Rating Scale (C-SSRS) Categories for Prospective Assessment (1 hour 33 minutes)
Speakers: Dr. Kelly Posner, Founder, Center for Suicide Risk Assessment at Columbia University/New York State Psychiatric Institute; Dr. John Greist, CEO, Healthcare Technology Systems and Mike Federico, Vice President, ePRO solutions, ERT Inc.
Description: Suicidality — or even the hint of it — can derail a trial. The FDA is concerned about suicidal thoughts and behaviors arising from — or compounded by — the use of investigational new drugs in clinical trials. In August, the agency issued a draft guidance with updated recommendations, including using the Columbia-Suicide Severity Rating Scale (C-SSRS). These improved data collection methods are of critical importance, as debunking false notions of risk and accurately identifying true risk are equally crucial from a public health perspective. In this presentation, the development team for the C-SSRS discusses their research, the FDA’s draft guidance and its implication and how to use the C-SSRS in multiple research settings.

Going "E" With Informed Consent for Clinical Trials (1 hour 28 minutes)
Speakers: Dr. Susan Brink, President and CEO, Consent Solutions Inc. and Sherri Bracy, Founder and Director, Bracy Consulting LLC.
Description: Join clinical trial specialists Dr. Susan Brink and Sherri Bracy in this presentation, as they answer these questions: What should you ask your IRB when initiating e-consent — how will they view the process and will it affect trial approval and monitoring?, How does a site/CRO or sponsor determine which e-consent application is the best fit for their organization?, What are the features that every e-consent application must have (e.g., revision control, audit trails)?, Tips and tricks for monitoring and auditing e-consents and Tales from the trenches — what are some of the common impacts an e-system has on the IRB process?

Medical Device Software Recalls on the Rise (1 hour 16 minutes)
Speaker: Dr. David Vogel, Founder, Intertech Engineering Associates
Description: In this presentation, device software expert Dr. David Vogel dissects these reports from a technical perspective to provide some understanding of what is behind this alarming 25% statistic. Listeners will gain an in-depth understanding of: Typical causes of software failures that lead to device recalls, What the FDA is doing to reduce medical device software failure rates, What manufacturers can do to improve their own software success rates and What materials, training and tools are available to build better software.

Off-the-Shelf Versus Custom-Built Quality Systems (40 minutes)
Speaker: Brian Dense, President, CiNQ Systems
Description: The FDA won’t tell you what type of quality systems — off-the-shelf or custom built — you should have. But what you decide plays a key role in whether you remain in their good graces. The key to success is picking the best systems for the way your company operates. For some firms, it’s off-the-shelf systems, for others it’s custom built. And rarely does a hybrid system work. But choosing between the two is a daunting decision. Brian Dense, president of CiNQ Systems and a 20 year veteran of the device industry will teach you how to get the right quality system for your business operation.

Your Clinical SOPs Are Too Long! (1 hour 24 minutes)
Speakers: Steven Steinbrueck, President, Stonebridge GCP Consulting and Elizabeth Bodi, Clinical Research Senior Consultant, Halloran Consulting Group
Description: Sponsors, CROs and site personnel are buried under the weight of long, overly bloated and wordy SOPs. A typical clinical SOP starts out being written by the clinical manager as a 4-page document, but by the time it is sent through pharmacovigilance, legal and the medical monitor, everyone adds their two cents and the document balloons to 12-15 pages. Has this ever happened to you? If so, read on… Too many organizations believe that filing cabinets full of 4-inch SOP binders and reams of paper make an effective program. This is just not the case. FDAnews has the answers. In this presentation, two of the industry’s best clinical SOP experts will teach you how to regain control of your SOP writing process, cut costs from duplicative writing activities and, most importantly, increase compliance.

Managing EMA Drug Process Validation (1 hour 20 minutes)
Speaker: Thomas Peither, President, Maas & Peither America Inc.
Description: On April 12, the EMA published its highly anticipated draft guideline for drug process GMPs. The EMA draft, which supersedes the 2001 Note for Guidance on Process Validation, embraces the life-cycle approach embodied in the FDA’s 2011 process validation guidance. A key feature of the EMA draft is a new approach called Continuous Process Verification (CPV) that supplants the old life-cycle approach. FDAnews invited an international drug manufacturing consultant to bring you up to speed. Thomas Peither is a specialist in GMP training, validation and audits. His firm serves clients from offices in King of Prussia, PA, and Germany. In a mere 90 minutes, you’ll gain an in-depth understanding of how to fulfill process validation requirements in both Europe and the U.S.

MDUFA 2012 (1 hour 18 minutes)
Speakers: Steven Niedelman, Lead Quality Systems and Compliance Consultant to the FDA & Life Sciences practice team, King & Spalding and Pamela Furman Forrest, Partner, King & Spalding
Description: Former FDA Deputy Associate Commissioner for Regulatory Operations Steve Niedelman and Partner in the FDA & Life Sciences Practice at King & Spalding, LLP, attorney Pamela Furman Forrest, provide essential guidance on the FDA Safety and Innovation Act and revisions to the medical device user fee authorization that will affect the medical device industry.  They provide strategies on achieving compliance, describe what new procedures and requirements devicemakers will face, as well as discuss what companies can expect the FDA to deliver during the next five years.

Insider Insight on PDUFA V (1 hour 29 minutes)
Speakers: Peter Barton Hutt, Senior Counsel, Covington & Burling; Erika Lietzan, Partner, Covington & Burling; Scott Cunningham, Partner, Covington & Burling and Stefanie Doebler, Special Counsel, Covington & Burling
Description: On July 9, 2012, President Obama signed the fifth Prescription Drug User Fee Act (PDUFA). The user fee reauthorization package provides the FDA with increased supply chain oversight powers, including authority to stop drug imports by uncooperative foreign manufacturers and abilities to share information with other international regulators. And that’s just the tip of the iceberg. In this presentation specifically created to address this legislation, former FDA Chief Counsel Peter Barton Hutt and colleagues Erika Lietzan, Scott Cunningham and Stefanie Doebler from Covington & Burling LLP give you the total picture of PDUFA V you need to ensure compliance.

Complying with FDA’s Unique Device Identification Rule (1 hour 17 minutes)
Speakers: Siobhan O’Bara, Healthcare Vice President, GS1 US and John Roberts, Director of Healthcare, GS1 US
Description: On July 3, 2012, the FDA released a proposed rule on the unique device identification (UDI) system, ending a year-long delay in finalizing the much-anticipated safety mechanism. The 165-page comprehensive rule touches all aspects of the medical device industry. The FDA maintains that the UDI system helps reduce the rate of death caused by faulty devices, which the agency estimates at 17,700 over the past five years. Jeffery Shuren, director of CDRH, called the UDI rule "a major game-changer." The FDA receives numerous device-related adverse event reports, but often can’t tell what device the patient is referencing. UDI makes aggregating reports easier, but at what time and cost to industry? Across the board — from supplier, provider, distributor, to consumer — who is ready? Listeners will learn what’s hidden in the rule’s 165 pages and where to start the journey to implementation. Siobhan O’Bara and John Roberts of GS1 will provide clarification on creating a mandatory system of unique device identifiers.

Medical Device Reimbursement De-Mystified (1 hour 17 minutes)
Speaker: Ed Dougherty, Senior Healthcare Advisor, Arent Fox
Description: With the Supreme Court decision and the FDA user fee reauthorization behind us, companies now have more certainty and new questions about regulatory and reimbursement pathways to securing value-based payment for innovative medical devices. Arent Fox Senior Health Care Advisor Ed Dougherty will present on securing value-based payment for medical devices in the current environment. The presentation will address best practices and recommend strategies for successful reimbursement planning for medical devices and diagnostics in the US. The discussion will draw together policy and tactics to create a "roadmap" for success.

Device Off-Label Promotion (1 hour 26 minutes)
Speakers: James Ravitz, Partner, Arent Fox LLP and Stephanie Trunk, Associate in the Health Law Group, Arent Fox LLP
Description: Last year, the device industry paid the Justice Department close to $1.8 million due to its stepped-up enforcement campaign to curb off-label marketing and violations of the False Claims Act. How can you minimize the risk of being investigated for an off-label promotion violation and ensure your promotional program is in compliance? Manufacturers could see a stronger crackdown on off-label promotion according to a March 2012 Office of Inspector General (OIG) report directing Health and Human Services (HHS) to focus on the practice. OIG flagged that issue among others as “weaknesses” with the FDA in its annual report on the top management and performance challenges facing HHS. Listen to James Ravitz, partner at Arent Fox LLP, and his colleague Stephanie Trunk in this presentation and get the total picture of device off-label promotion you need to ensure compliance, avoid serious penalties and protect your reputation.

Understanding the U.S. Biosimilar Pathway in 2012 (1 hour 45 minutes)
Speakers: Erika Lietzen, Partner, Covington & Burling and Laura Sim, Associate in Food & Drug practice group, Covington & Burling
Description: On Feb. 9, the FDA threw open the floodgates, issuing three draft guidances that promise to provide a roadmap for biosimilars development. And they opened up a public comment period that generated some serious discussion. FDAnews called on two experts in regulatory law, Covington & Burling’s Erika Lietzen and Laura Sim, to explain what the FDA is trying to do, how the public comments might change the landscape and what you need to know NOW in order to stay out in front.

Process Validation for Medical Devices (1 hour 39 minutes)
Speaker: Dan O’Leary, President, Ombu Enterprises
Description: Three FDA Centers (CDER, CBER and CVM) adopted a new guidance document on process validation — CDRH did not. While CDRH had planned to adopt the GHTF guidance document, those plans have stalled. Without guidance, device manufacturers may not get a clear-cut direction on which process to validate and when they need validation. Dan O’Leary, president of Ombu Enterprises, will provide answers to your questions about setting up an effective system.

Inspectional Readiness (1 hour 27 minutes)
Speakers: Julie Larsen, Director Inspection Readiness Services, BioTeknica Inc. and Arnold Solomon, President, FDA Strategic Compliances LLC
Description: This one-of-a-kind presentation can help you turn an FDA inspection nightmare into a dream! The manner in which these inspections are handled can have a major impact on the results. The appropriate handling of inspections can affect the timing of approvals and may mean the difference in whether the agency takes a regulatory action or grants a product approval. In just 90-minutes, have your SMEs and team ready for game time.

Physician Payment Sunshine Act (1 hour 26 minutes)
Speakers: Michaeline Daboul, President and CEO, MMIS Inc. and Tim Robinson Esq., Executive Vice President and General Counsel, MMIS Inc.
Description: Rules implementing the Physician Payment Sunshine Act are bearing down on the drug and device industries. On May 2, CMS Acting Administrator Marilyn Tavenner stated that the final rule will be issued by the end of this year with implementation required 90 days after issuance date. This presentation is serious. Listeners will get an in-depth look at what device and pharmaceutical companies need to learn now and how to participate and comply with the CMS Sunshine Act.

510(k) Process Changes Survival Guide (1 hour 9 minutes)
Speakers: Neil O'Flaherty, Principal, Olsson Frank Weeda Terman Matz PC (OFW Law); Evan Phelps, Principal, OFW Law and Nancy Mathewson, Associate, OFW Law
Description: On Dec. 27, 2011, the FDA gave the industry a belated holiday gift: A series of guidances intended to put to rest the controversy regarding 510(k)-related clearances. But has it succeeded? The jury is still out. Many are still wondering about that footnote that appears to have scraped the use of “split predicates.” And is it possible to defy long-held beliefs and use more than 5 predicates? What about the six-step flowchart the FDA is going to employ? A “no” on any one of 4 out of 6 steps will get your device ruled not substantially equivalent. Are you prepared?

Part 806 Device Recalls (1 hour 13 minutes)
Speaker: Gordon B. Richman, Vice President, Strategic Compliance Consulting and General Counsel, EduQuest
Description: Damned if you do, damned if you don’t. That’s the feeling many have in trying to comply with recalls related to 21 CFR Part 7 and 21 CFR Part 806. Under 21 CFR Part 7, you are requested to report corrections or removals to your FDA District Recall Coordinator promptly. But under 21 CFR Part 806, you are required to report within 10 business days after initiating such corrections or removals. Not only are devicemakers running afoul of the FDA on this point, but they're likely to under-report field actions by misinterpreting CFR Title Part 806. While Part 806 requires you to report recalls, it also has some exemptions. But devicemakers are finding it confusing to decide when and how to apply the exemption. Many device companies are getting themselves into trouble because they don't fully understand how to reconcile the FDA's general recall requirements under Part 806 and the enforcement provisions of Part 7. Can they really be seamlessly integrated? Yes they can. And FDAnews has brought in one of the industry’s top experts to help. Gordon Richman of EduQuest clarifies the critical differences.

Dietary Supplement GMP Inspections and Violations (1 hour 25 minutes)
Speakers: Dean Cirotta, Vice President, EAS Consulting Group and William Ment, Contract Consultant, EAS Consulting Group
Description: Dietary supplement makers: That knock you hear at the door? It’s probably the FDA. In 2007, the FDA declared mandatory GMP compliance for firms like yours. You had it a bit easier compared to the scrutiny drug- and devicemakers face. Recently, dietary supplement makers have been embroiled in lawsuits and seizures, 483s and warning letters as the agency starts turning up manufacturing violations. Welcome to real life. Are you prepared?

Medical Device Complaint Management (1 hour 26 minutes)
Speaker: Susan Reilly, Owner and Principal Consultant, Reilly & Associates LLC
Description: It’s simply not good enough to say your complaint management system is compliant with CFR Part 820 — Quality System Regulation. The FDA would also like it integrated with multiple other sections of the CFR and international regulations. Here’s the opportunity to find out — now — what you’ll be facing in the future.

Legal and Regulatory Guide to EU’s New Pharmacovigilance Regulations (1 hour 5 minutes)
Speaker: Elisabethann Wright BL, Partner, Hogan Lovells International
Description: On July 2, 2012, the European pharmaceutical industry will change forever. The EU has published what was been described as the largest transformation covering pharmacovigilance in more than a decade. If you’re a marketing authorization holder (MAH) you’ll need to comply. Will you be ready?

Develop a Process Validation Roadmap (1 hour 18 minutes)
Speaker: Rich Yeaton, President, East Coast Validation Services LLC
Description: If you haven’t started revalidating your processes and using your change control SOPs, you’re headed for 483s and recalls that could cost millions of dollars. Last year’s process validation (PV) guidance is both daunting and difficult. Most drug and biologics manufacturers aren’t really sure how to comply with the new PV guidance. Many don’t even want to apply the guidance to avoid having to revalidate their processes. The FDA has significantly changed its approach to process validation. You risk costly enforcement if you haven’t aligned your change controls, monitoring and trending efforts. Now, this presentation helps you do it all with an easy-to-follow roadmap that has already helped companies with complex processes achieve compliance. Process validation expert Rich Yeaton shares his road-tested “roadmap” — a template that will enable you to use your existing PV data to satisfy regulators. Plus, he’ll share case studies of how three companies like yours have used the roadmap successfully.

Requirements for Effective Environmental Monitoring Plans (1 hour 30 minutes)
Speaker: Kenneth Christie, COO, Consulting Services at VTS Consultants Inc.
Description: The news is full of recent high-profile pharma, biologic and contract manufacturers with contamination problems and other failures in their environmental monitoring processes. And the FDA is hot on the trail of companies that violate GMP standards. What is your environmental monitoring plan missing for 24-hour observation and containment? This upcoming webinar tells you what it takes to find and fix all sources of potential contaminants at your facility, day or night. Is your environmental monitoring plan FDA-ready? Are you sure?

Pharma/Device Social Media: What You Can and Can’t Do Today (1 hour 35 minutes)
Speakers: Michelle Sherman, Editor and Contributing Author to the Social Media Law Update blog, Sheppard Mullin Law Firm and Seth Mailhot, Special Counsel, Sheppard Mullin Law Firm
Description: The FDA is making good on its plan to issue guidance regarding social media with 2 issued and 4 more to go. Should you wait or develop a strategy now? Despite the guidances there seems to be as many unwritten rules as written ones and it’s become pretty confusing for pharma and device companies to “color inside the lines.” Guessing is not a strategy you want to use. Instead, let two of industry’s most-respected experts show you how to use the recent FDA guidances and currently deployed social media approaches to meet your media needs and remain compliant.

Managing Data Integrity and Part 11 Compliance for Device Suppliers (1 hour 18 minutes)
Speaker: John Avellanet, Managing Director, Cerulean Associates LLC
Description: Devicemakers — Recent warning letters point to increased focus on ensuring that your suppliers are delivering validated data and software. Read on ... Device manufacturers — How do you really know if the data and software from your suppliers is actually validated and meets FDA requirements? The FDA is focusing on the handoff of data and software from suppliers to device manufacturers. Validation takes time and money and, by the time FDA flags you or your supplier for unreliable data, it may be too late. Fortunately, help is around the corner.

Controlling Cross-Contamination in Outsourced Manufacturing (1 hour 25 minutes)
Speakers: Kevin Rosenthal, Director of Manufacturing, Pharmatek Laboratories Inc. and Stephanie Wilkins, PE, Lean Six Sigma Green Belt
Description: Drug sponsors’ #1 concern with contract manufacturers is managing cross-contamination prevention and handling capabilities, according to a recent survey. One molecule. In some cases, just one stray molecule is all it may take to adulterate — and ruin — a costly batch of your products. Drug/biologics manufacturing has entered a new era, one where manufacturing tolerances — especially for certain biologics and small-molecule pharmaceuticals — have grown incredibly tight, even as drugmakers rely ever more heavily on far-flung networks of contract manufacturing organizations (CMO). Balancing the demand to reduce costs through outsourcing and maintaining current good manufacturing process compliance is tough. No one can deny that. But a cross-contamination disaster will cost 10 times the savings you were hoping for. And might cost you your job. This presentation is an inexpensive insurance policy to assure you have the right CMO for your job and to provide tools to help you manage and audit them going forward.

Registering “Applicable Trial” Data on ClinicalTrials.gov (1 hour 55 minutes)
Speaker: Scott Cunningham Esq., Partner, Covington & Burling LLP
Description: Three little words, “applicable clinical trial.” How have they become so difficult to understand when it comes to registering trials on ClinicalTrials.gov? With reports of industry “cherry picking” on the rise — and new rules currently in development — now’s the time to get expert guidance. While the Food and Drug Administration Amendments Act of 2007 (FDAAA) requires that sponsors and clinical investigators register all applicable clinical trials and report the results of these trials on the National Institutes of Health’s (NIH) ClinicalTrials.gov website, many are accused of cherry-picking and only reporting positive trial outcomes. Yet, is it cherry picking or confusion on what constitutes an applicable clinical trial? Regardless of your answer, the NIH, FDA and OIG are ramping up enforcement of the requirements and are increasing pressure on firms to report all applicable clinical trials. In 2010, three firms were mandated to comply with registration and reporting requirements through OIG corporate integrity agreements. It’s a looming crisis for the clinical trials community. Fortunately, help is at hand.

eCTD Requirements Under PDUFA V (1 hour 30 minutes)
Speaker: Antoinette Azevedo, Principal, e-SubmissionsSolutions.com
Description: FDA's refusal to accept your submission and its underlying datasets can bring years of R&D, clinical and regulatory work to a grinding halt — costing you hundreds of millions of dollars in lost profits and millions more in expenses to rework. Add the upcoming PDUFA V reauthorization which is expected to mandate eCTD format for all new chemical/biological entity submission types to CDER and CBER — this includes INDs, NDAs and BLAs — and you have the “perfect storm” for submissions specialists. This will especially hit hard small and mid-sized companies who only do INDs, as well as investigators in academic settings. While PDUFA V is 13 months away, and a transition period is provided, a conservative timeline dictates that you need to start now -- remember, your validated processes and systems must go live 6 to 12 months prior to any FDA deadline. This webinar will give you the tools, intel and strategy to start today and be prepared to purchase, implement, validate and go live with fully functioning, compliant systems.

Adaptive Clinical Trial Design and Model-Based Drug Development (1 hour 55 minutes)
Speakers: Olga Marchenko, Vice President, Quintiles Inc. and Seth Berry, Director of Clinical PK-PD Modeling and Simulation, Quintiles Inc.
Description: This special 2-½ hour, two-part session: you’ll learn about the 10 reasons to use adaptive designs in dose-ranging studies, and 10 benefits of modeling and simulation in drug development. And you’ll walk away with the tools you need to save your company time and money. In its first extended-length 2 ½-hour webinar, FDAnews is pleased to bring you the latest on adaptive clinical trial design and model-based drug development.

Marketed Unapproved Drugs (1 hour 3 minutes)
Speaker: Kurt Karst, Director and Attorney, Hyman, Phelps & McNamara P.C.
Description: As of September 19, 2011, all unapproved drugs introduced onto the market are subject to immediate enforcement action. FDA’s new guidance on Marketed Unapproved Drugs is stronger than the 2006 crackdown that resulted in dozens of warning letters and consent decrees. This time, there are six specific priorities for stepped-up enforcement — and enforcement action can occur at any time without prior notice and without regard to prior enforcement policies. Could the FDA target you? Here’s how to get ready. Fast.

Spreadsheet Validation (1 hour 30 minutes)
Speaker: David Harrison, Principal Consultant, ABB Engineering Services
Description: Do your Microsoft Excel spreadsheets pass FDA muster? Sign up now for a hands-on learning experience by a spreadsheet validation expert. You’ll discover best practices, tips, tricks ... and much more. What if you could perch on the shoulder of an expert on spreadsheet validation ... look on in real time as he posts entries and manipulates cells ... ask why he does this instead of that ... and get feedback? What if you could discover the tips and tricks that will help you streamline your spreadsheet validation process for quick-and-final FDA approval? Well, you can.

Reduce Human Error on the Drug and Device Manufacturing Floor (1 hour 36 minutes)
Speaker: Ginette Collazo Ph.D.
Description: Human error causes 80% of drug and device manufacturing failures, studies indicate. To uncover the secrets of reducing human error, improving your products and fending off the FDA, read on ... What causes drug and device manufacturing failures and recalls? Human error. Time after time, CAPA investigations single it out as the root cause of violations. If there were a magic formula for ending human error, we’d share it. But here’s the next best thing — systematic best practices and strategies that have been proven to cut human error and boost success on the factory floor. Learn them yourself — in half an afternoon.

A Snapshot of Social Media in Pharma: The Why, What and How (51 minutes)
Speaker: Casey Ferrell, Market Research Analyst, Cutting Edge Information
Description: Facebook and Twitter. They ought to represent the marketing breakthrough of the new century. But so far, they’re techniques that could cause you trouble. While there has been lots of talk, the FDA has failed to issue guidance, leaving drug- and devicemakers in the dark — and vulnerable to sanctions. With surveys showing 60% of Americans turn first to the Internet when seeking health information, is there a safe way to get your message out via social media? The answer is yes — when you know what you’re doing.

Surviving the FDA’s New PREDICT Import Screening Program (1 hour 33 minutes)
Speaker: Benjamin L. England Esq., Founding Member, Benjamin L. England & Associates LLC
Description: The FDA’s PREDICT system is dramatically changing the way the agency screens drugs and medical devices arriving in the US. For years, the FDA relied largely on entry document review and intuition in deciding which imports to detain for testing and scrutiny and which to let pass without review. With PREDICT, that’s all changing. This new system is great news for those companies that understand how it works and take advantage of its new features. But it will be big trouble for those companies that do business the same old way. The PREDICT system allows the FDA to take into consideration a whole array of new information to determine whether to examine a shipment – information that was not generally available to its inspectors before.

Form 483 and Warning Letter Responses (1 hour 9 minutes)
Speaker: Gordon B. Richman, Vice President, Strategic Compliance Consulting and General Counsel, EduQuest
Description: The recent trend of increasing FDA inspections and warning letters is continuing this year, as the agency has already issued 874 letters in fiscal 2011, compared with 673 last year. From fiscal 2005 to fiscal 2009, the number of warning letters issued per year hovered in the high 400s. With increased staffing, the agency has doubled the number of establishment inspection reports reviewed, from 215 in 2006 to 416 in 2011. As heightened inspections — and warnings — become the “new normal,” it’s vital to know what’s triggering citations and what to do if you’re hit with a Form 483. In fact, the more you know about how to handle 483s, the more power you have to handle things without facing subsequent warning letters, consent decrees … and even recalls. Now, FDAnews helps you mount a timely, effective response to keep inspection citations from leading to further costly consequences.

QSR Data and Trending (1 hour 14 minutes)
Speaker: James Eric Miller, Core Quality Systems Senior Quality Analyst, Roche Diagnostics
Description: An overlooked requirement within the Quality System Regulation (QSR) is quickly moving up the audit checklist of FDA investigators. QSR Section 820 doesn’t mention the word “trend,” but the FDA has demonstrated in 483s and warning letters that it expects companies to analyze and trend their quality data — and then act on what they’ve learned. But most companies don’t know the scope of the requirements, let alone how to react to them. Is yours one of them?

Root Cause Analysis (1 hour 39 minutes)
Speaker: Michele Piepoli, Managing Director, MHP Consultants LLC
Description: Learn what the FDA doesn’t teach you ... about CAPA and “root cause” compliance. The FDA requires you to comply with risk-based CAPA by creating documented systems for discovering the root cause of system failures, process exceptions and nonconformances. Your root cause analysis should identify why things go wrong … then make sure they don’t happen again. But the FDA doesn’t teach youhow to do a root cause analysis. That’s where we come in. Now you can learn the fundamentals from a veteran consultant who has reviewed hundreds of failure investigations.

Clinical Trial Billing Under Medicare (1 hour 36 minutes)
Speakers: Kevin R. Eskew, Managing Director, SNR Denton Health Care Group and Lisa Murtha Esq., Member, Sonnenschein Health Care Group
Description: In this 90-minute webinar, Kevin Eskew and Lisa Murtha discuss the Medicare Clinical Research Coverage Policy — how to negotiate a clinical trial budget that keeps your sites operating and billing in compliance. Learn which costs are billable to third-party payers and why sites have trouble billing appropriately.

U.S. and EU Individual Case Safety Reports (1 hour 21 minutes)
Speaker: Graeme Ladds, CEO, PharSafer Associates Ltd.
Description: Regulators worldwide have grown weary of safety concerns not reaching them fast enough. The FDA and EU are tackling this problem by implementing a new international data standard and reporting system — HL7 ICSR. In the U.S., this standard for drugs and biologics will be finalized soon, sometime in mid-2011. What does this mean for you? Individual Case Safety Reports and the ICH E2B(R3) Implementation Guide is your next big challenge. Pharmacovigilance data management will never be the same. This webinar, led by Graeme Ladds, an accomplished pharmacovigilance expert and author, will lead you step-by-step through the jungle of U.S. and EU implementation differences, data conversions, common errors and quality/accuracy cross-checks.

Drug-Induced Liver Injury (1 hour 16 minutes)
Speaker: Einar Bjornsson, Professor of Gastroenterology and Hepatology, Landspitali University Hospital
Description: Despite two years of guidance regarding data capture methods, drug-induced liver injury (DILI) continues to plague clinical trials. How can you minimize DILI risks without risking your patients? DILI has been the most frequent single cause of safety-related drug marketing withdrawals for the past 50 years. Hepatotoxicity discovered after approval for marketing also has limited the use of many drugs. Several drugs have not been approved in the United States because European marketing experience revealed their hepatotoxicity. Internationally known expert Einar Bjornsson has focused on this topic and has worked hard to validate Hy’s Rule along with other tricks to determine unacceptable levels of hepatotoxicity.

FDA’s Electronic Source Documentation Guidance (1 hour 33 minutes)
Speaker: Dr. Jules Mitchel, President, Target Health Inc.
Description: In the clinical trial arena the new mantra is “less is more.” Less paper equals more products to market faster. If you’re looking to decrease time to database lock … develop fully electronic final study reports and regulatory submissions, now’s your chance to learn how. Read on. In the year and a half since the FDA released its draft guidance “Electronic Source Documentation in Clinical Investigations,” technology has become more readily available to pharmaceutical companies willing to jump on the paperless bandwagon. Many companies remain uncertain of the technologies and are rapidly falling behind. Now — before the FDA guidance becomes final — is the time to learn more. In 90 fast-paced minutes, Dr. Mitchel will demonstrate how to hit the ultimate goal: faster market launches.

eMDR Conversion and Implementation (1 hour 30 minutes)
Speaker: Eugene Reilly, Public Health Analyst, FDA Center for Devices and Radiological Health Office of Surveillance and Biometrics
Description: In a few short months, a final rule from the FDA will require devicemakers to begin filing medical device reports electronically. Once you begin filing electronically, the FDA will expect you to file everything electronically, including: initial reports; supplemental/follow-up reports; file attachments (as PDFs or zips); and source (e.g., user facility) reports. It’s a learning curve, best climbed early, advises the FDA’s Indira Konduri: “Assistance from the FDA will be easier now — before it’s mandatory — and you’ll be ready to go when eMDR is mandated.” Here’s your opportunity to have an FDA official answer your questions — and more. Read on ... For devicemakers, a major change looms in dealings with the FDA. Sometime this summer, the way reports of death and serious injury are filed is to go electronic. No more paper. No more Excel spreadsheets. You have a lot to learn about eMDR ... and only a short time left to do it. Who better to ask for guidance than the FDA?

Standardizing REMS (1 hour 29 minutes)
Speaker: Edward Fotsch M.D., CEO, PDR Network LLC
Description: 75% of drug industry stakeholders see the FDA’s intent to reform individualized REMS programs as a good thing. But things appear a bit stalled. Despite this delay, you can still move ahead with your own preparation for standardized REMS. Here’s how … What can you do now to assure you’re ready to comply — and benefit from — the standardization of REMS? Plenty. That’s because various industry groups and associations are hard at work hammering out real-world REMS reference guides that map out what you can do today to improve your programs and anticipate what the FDA guidance is likely to include.

Comparative Effectiveness Research (1 hour 17 minutes)
Speaker: Josh Feldstein, President, Joint Center for Applied Value Analysis and Principal, MarCom Group International
Description: Are you struggling to counter your customers short-term fixation on price? Do you wish they would look at the long-term consideration of total cost and the overall value associated with using your drug or device? If so, you need a comparative effectiveness research crash course. Especially since looming mandates requiring comparative effectiveness research evaluations are on the horizon. Industry — and more importantly, state and federal payers — is increasing the use of and support for total value metrics and sophisticated value analysis models. For 25 years, Josh Feldstein has been at the forefront of developing total value metrics and value-based models, and teaching firms how to establish and promote a comparative effectiveness research culture. This webinar is designed to bring you tangible tips and strategy-changing insights that will jumpstart — or beef up — your own comparative effectiveness research (CER) program.

Off-Label Promotion — The Elephant in the Room (1 hour 29 minutes)
Speaker: Sara Dyson Esq., Assistant VP for Loss Control, Medmarc Insurance Group
Description: Off-label promotion is illegal — that’s a well known fact. What you might not know is that your firm could face significant product liability (and other) lawsuits because of off-label violations. Here’s how to educate your staff about the regulatory, legal and product liability pitfalls of off-label promotion. If your company loses a product liability lawsuit, it could cost thousands (even millions) of dollars. It could also cost you your job. This is not mere scare talk. The Justice Department has been working on 200+ investigations of off-label violations involving some 500 products. And the FDA’s Office of Criminal Investigations (OCI) maintains a special prosecutions staff to look into illegal off-label promotion of approved devices and drugs. Yet far too many drug and device company employees simply don’t know the rules. Training is spotty, sometimes nonexistent. Here’s how to learn what you need to know.

How to Align the FDA Approval Process with Paragraph IV Strategy (58 minutes)
Speaker: Chad Landmon Esq., Partner, Axinn Veltrop & Harkrider LLP
Description: To learn about these innovative ways to snag more approvals, mark your calendar for Thursday, June 2, 2011, when leading FDA lawyer Chad Landmon, Esq. will show how you too can revive approvals without scorched earth legal machinations.

Preparing for an FDA Preapproval Inspection (1 hour 36 minutes)
Speakers: Frederick H. Branding RPh JD, Principal Attorney, Olsson, Frank, Weeda, Terman, Bode and Matz P.C. and Cathy L. Burgess, Partner, Olsson, Frank, Weeda, Terman, Bode and Matz P.C. Health Care Group
Description: Join Frederick Branding and Cathy Burgess for this 90-minute webinar and discover how to prepare for and manage these inspections to avoid misunderstandings, prevent delays in the approval process and eliminate unnecessary costs.

Reducing Gender Disparities in Device Clinical Trials (1 hour 12 minutes)
Speaker: Rita Redberg M.D., Professor of Medicine, Division of Cardiology, University of California-San Francisco School of Medicine
Description: In 90 fast-paced minutes, Dr. Rita Redberg of the UCSF School of Medicine offers a sneak preview of what the FDA guidance is likely to say, as well as interim policy improvements the agency has released.

Risk Strategies in Clinical Trial Contracts (1 hour 31 minutes)
Speaker: Joan Antokol, Managing Partner, Park Legal LLC
Description: With millions of dollars at stake in a clinical trial, the indemnification clause is considered one of the most contentious issues that arise in sponsor negotiations, according to the American Association of Medical Colleges. Yet it need not be a source of conflict — there are simple ways to deal with the negotiable clause elements that are widely accepted by nearly every company and institution. How can you ensure the right language is written into your clinical trial agreements (CTAs) — language that can protect you in the event a malpractice lawsuit is filed? In this presentation, attorney Joan Antokol will show you how to efficiently and effectively negotiate a CTA indemnification clause that ensures you won’t risk millions of dollars in the event a lawsuit is filed and you are not indemnified for that loss. Her presentation will feature case studies using real, specific clauses found in actual CTAs.

Medical Device Complaint Systems (1 hour 42 minutes)
Speaker: Dan O’Leary, President, Ombu Enterprises LLC
Description: This FDAnews-sponsored webinar features Dan O’Leary, a 30-year veteran of the quality wars, laying out what device and diagnostics makers like you need to know today. In 90 fast-paced minutes, Mr. O’Leary covers when (and how) to determine the components of an integrated system, conduct gap analysis, file either a 5-day or 30-day MDR report, as appropriate, determine when a 10-day corrections or removals (C&R) report is needed, learn about overlapping reporting requirements for MDRs and C&Rs, and map the process flow in an integrated complaint management system.

A World Apart (1 hour 30 minutes)
Speakers: Steven Datlof MD JD, Partner, Hogan Lovells and Elisabethann Wright BL, Partner, Hogan Lovells International
Description: The FDA recently estimated that more than 10,000 adverse event reports for medical devices are submitted annually in the U.S., with an even higher number reported in the E.U. Failure to understand adverse event reporting in either the U.S. or the E.U. can result in faulty clinical trials and warning letters. Make an important decision today. Learn how to bulletproof your adverse event reporting protocols by attending this presentation.

GLP Compliance (1 hour 9 minutes)
Speaker: Anne Maczulak PhD RQAP-GLP, Principal Consultant, Acorn GLP Consulting
Description: You can count on death, taxes ... and GLP inspections. They’re no fun to undergo, but possible to pass with the proper preparation. To find out how, read on. GLP inspections are like taxes: Hard to avoid, and just about as much fun. If you’ve ever been through a GLP inspection — and few drug or biologics execs have not — you don’t look forward to the next one. But as with taxes, you know the day must come. This time around, why not ease the pain? Why not start getting ready now? Sign up for the GLP “boot camp,” sponsored by FDAnews and conducted by a top consultant in GLP and QA training, Anne Maczulak of Acorn GLP Consulting. In only 90 minutes, you’ll learn (or re-learn) the basics — the 10 steps that make short work of preparing for an inspection. By the end of the webinar, you’ll feel more secure about being in compliance and avoiding 483s or warning letters.

New EU Annex 11 Rules: Part 11’s Get-Tough European Cousin (1 hour 30 minutes)
Speaker: Martin Browning, President and Co-Founder, EduQuest
Description: For the first time in EU history, Annex 11 will require your company to manage risks throughout the life of any computerized system used in a regulated activity, effective June 30, 2011. The new rules will mean retooling validation, risk management and documentation … including everything from electronic signatures and simple spreadsheets to product quality systems and complex, company-wide networks. Sanctions for noncompliance will be stiff … so the stakes are high for making your systems and processes compliant. Bottom line: when the new rules take effect June 30, will you be ready … or at risk? What new steps and strategies will you need to protect yourself from validation violations under the new EU rules? Get real-world guidance — in time to make a difference — from Martin Browning, one of industry’s top validation compliance experts and a former FDA investigator.

Dissecting the Drug and Device Industries’ Leading Legal Cases (1 hour 19 minutes)
Speaker: Alan Minsk, Partner and Chair of the Food & Drug Practice Team, Arnall Golden Gregory LLP
Description: No matter how quickly the courts redefine and reinterpret complex rules, you can be sure that the FDA will expect your legal, regulatory and compliance team to keep you on top of the changes — and in compliance with what’s required. With so much at stake, why not avoid the risk of noncompliance by registering for this timely FDAnews webinar?

Practical Approaches to Lifecycle Signal Detection (1 hour 17 minutes)
Speaker: Elizabeth Garrard PharmD. R.Ph., Chief Safety Officer, Drug Safety Alliance Inc.
Description: The EMA has found that statistical signal detection can provide more than a 50 percent increase in the detection of many drug-related problems … and has recommended it be added to routine pharmacovigilance for optimal safety in the monitoring of drugs. This webinar, covering the practical approaches of signal detection (and other new innovations) will help you get an early start towards understanding signal detection and implementation.

Spreadsheet Validation (1 hour 40 minutes)
Speaker: David Harrison, Principal consultant, ABB Engineering Services
Description: Do your Microsoft Excel spreadsheets pass FDA muster? Sign up now for a hands-on learning experience by a spreadsheet validation expert. Plus, you’ll learn about third-party software features that improve security and audit trail capabilities within Microsoft Excel spreadsheets ... and see examples of documentation contents and test scripts used during validation. You’ll discover best practices, tips, tricks ... and much more.

Supplier Quality Management (1 hour 23 minutes)
Speaker: Steven Sharf, President, GMP Concepts
Description: When it comes to the nuts and bolts of supplier quality management, the FDA has left drug and device makers somewhat in the dark. Take this opportunity to understand strategies for ensuring supplier quality — without busting the budget. In 90 fast-paced minutes, Steven Sharf will explain ways you can address the risk associated with accepting your suppliers’ CoA. Not only will you be able to explore reduced inventory levels, but you will also become more intimate with your suppliers’ operation and ultimately build stronger and better relationships.

Social Media Strategies for Pharma (1 hour 10 minutes)
Speaker: Zoë Dunn, Independent Digital Marketing and Communications Consultant
Description: What's the proper way to weave post-marketing submission requirements into your social media strategy? What accountability do manufacturers, packers and distributors have for online communications? FDA inspectors have already learned the answers. And now you can, too. You really can't afford to wait, with the internet and sites like Facebook and Twitter playing a crucial role in your future. So, take a proactive step. Sign up for this webinar today and learn exactly what you can and can't do in beginning to build your social media presence now.

Form 483 and Warning Letter Responses (1 hour 23 minutes)
Speaker: Gordon B. Richman, Vice President, Strategic Compliance Consulting and General Counsel, EduQuest
Description: As heightened inspections — and warnings — become the “new normal,” it’s vital to know what’s triggering citations and what to do if you’re hit with a Form 483. In fact, the more you know about how to handle 483s, the more power you have to handle things without facing subsequent warning letters, consent decrees … and even recalls. Now, FDANews helps you mount a timely, effective response to keep inspection citations from leading to further costly consequences.

Perspectives on the FDA Guidance for Suicidality Monitoring in Clinical Trials (1 hour 22 minutes)
Speaker: Kelly Posner Ph.D., Founder, Center for Suicide Risk Assessment at Columbia University/New York State Psychiatric Institute
Description: To help drug and biologic manufacturers deal with potential suicidality in their INDs, the FDA issued a September 2010 draft guidance requiring sponsors to prospectively assess suicidality in their clinical trials. It recommended using two suicide assessment tools. A team headed by Columbia University Professor Kelly Posner designed the Columbia Classification Algorithm for Suicide Assessment (C-CASA) and the Columbia Suicide Severity Rating Scale (C-SSRS) mentioned in the guidance. This presentation explains how C-CASA and C-SSRS work... and how you can use them in your own clinical trials.

Medical Device Quality Audits (1 hour 32 minutes)
Speaker: John Gagliardi, President, MidWest Process Innovation LLC
Description: When it comes to complying with 21 CFR 820.22, the regulation’s scant 109 words don’t offer much guidance for conducting medical device quality audits. What those words do provide are grounds for FDA investigators to cite you for everything from improper documentation … to noncompliant corrective action plans … to having the wrong people on your internal audit team … and more. Here’s how to avoid the mistakes that lead to 483s … the first time around. Not only will you benefit from this “how-to” lesson on coping with 820.22, you’ll come away with a bonus — a battle-tested checklist for conducting quality audits that meet FDA expectations.

Organizing Data & Doc Archives (1 hour 39 minutes)
Speakers: David Chesney, Quality and Compliance Management Services Vice President, PAREXEL Consulting and Peter D. Smith, Vice President for Pharmaceutical Compliance, PAREXEL
Description: Paper documents unscanned. Naming conventions that don’t make sense. Emails as documentations. Poor communication with the vendors that generate your data. Non-functional (or non-existent) SOPs. Documents missing altogether. Yes, data retrieval is in a sorry state at far too many drug, device, biologics and diagnostics companies. FDAnews has invited a leading GCP/GLP/GMP consultant to help you get control of your data. In 90 fast-paced minutes on your own desktop, you’ll learn the basics of developing best practices and SOPs that turn inspection nightmares into routine management tasks.

Designing & Executing Observational Studies (1 hour 12 minutes)
Speaker: Peggy Schrammel, VP-Registries and Post Approval Development, United BioSource
Description: With the dawn of the era of evidence-based medicine, many tools have been developed that can prove the superiority of your products. Question is ... do you know how to use them? Will the observational studies you create deliver accurate, reliable data? Do you have the skill set to construct patient registries that are flawless ... or flawed? If you answered “No” ... or even “I don’t know” ... then this presentation will get you up to speed.

Electronic Health Records and REMS  (1 hour 36 minutes)
Speaker: Edward Fotsch M.D., CEO, PDR Network LLC
Description: The American Recovery & Reinvestment Act — commonly called the healthcare reform bill — contains a $20 billion carrot to speed adoption of EHRs. Checks are already flowing from the government to healthcare providers across the country in support of this initiative. Many healthcare providers are already jumping on the electronic system train and switching over to these newer more efficient systems. If you’re not yet among them, this FDAnews presentation is designed to get you on board and ready to move ahead. For starters, you’ll discover how taking this integrated approach cuts time and cost from meeting your regulatory obligation to communicate REMS elements. Plus, you’ll learn how CMS’ definition of “meaningful use” can help you turn your REMS elements into a powerful competitive advantage with healthcare providers.

New Safety Reporting Requirements for Drugs and Biologics (1 hour 37 minutes)
Speakers: Joan Antokol, Managing Partner, Park Legal LLC and Dr. John (Jack) McLane, COO, Clinquest Inc.
Description: In 90 fast-paced minutes, Joan Antokol, Managing Partner at Park Legal, LLC and Dr. John McLane, COO and VP Clinical and Regulatory Affairs with Clinquest Inc., will analyze the final rule and guidance, advise how to manage individual safety events in various settings, and offer compliance tips for sponsors, CROs and investigators.

Root Cause Analysis (1 hour 18 minutes)
Speaker: Michele Piepoli, Managing Director, MHP Consultants LLC
Description: Your root cause analysis should identify why things go wrong … then make sure they don’t happen again. But the FDA doesn’t teach you how to do a root cause analysis. That’s where we come in. In 90 information-packed minutes, you’ll learn the fundamentals from a veteran consultant who has reviewed hundreds of failure investigations. 

Purchasing Controls for Medical Device Manufacturers (1 hour 32 minutes)
Speaker: Dan O’Leary, President, Ombu Enterprises LLC
Description: The FDA’s purchasing controls regulation, along with GHTF/SG3/N17R9:2008 — commonly known as Guidance on the Control of Products and Services Obtained from Suppliers — have turned into headaches for the entire device and diagnostics community, including OEMs, contract manufacturers, even supplier of raw materials, as device regulators including the FDA, the EMA and others toughen up on supply-chain issues. But, you can clean house … get up to speed … and avoid being the next to get a warning letter ... all in just 90 minutes.

Reduce Supply Chain Risks (1 hour 25 minutes)
Speaker: Martin Browning, Founder and President, EduQuest
Description: Let former top FDA investigator Martin Browning bring you up to date as he explains how the FDA expects you to manage and monitor outsourced activities in your supply chain. He’ll examine best practices for making outsourcing decisions and what you need to do to keep the FDA informed. Plus, you’ll find out how to navigate all the agency’s rules and regulations — and much more.

Clinical Trial Billing Under Medicare (1 hour 42 minutes)
Speakers: Holley Thames Lutz Esq., National Chair, Sonnenschein Health Care Group and Lisa Murtha Esq., Member, Sonnenschein Health Care Group
Description: In this presentation, noted attorneys Holley Lutz and Lisa Murtha discuss the Medicare Clinical Research Coverage Policy — how to negotiate a clinical trial budget that keeps your sites operating and billing in compliance. Learn which costs are billable to third-party payers and why sites have trouble billing appropriately.

Supplier Quality Agreements for Warehouses & Shippers (1 hour 10 minutes)
Speaker: Jim Darnell, Managing Consultant, Tunnell Consulting
Description: Today, you need comprehensive quality agreements with your wholesalers, warehouses and shippers. And every minute you operate without them, you’re at risk for enforcement actions. What should quality agreements say? What’s the smartest way to negotiate terms that will work for the FDA and everyone in your supply chain? And what’s in the regulatory fine print that you need to know to avoid 483s and warning letters? Don’t miss your chance to learn how to negotiate, draft, implement and audit supply quality agreements that assure compliance with FDA regulations.

Bayesian Statistics in Medical Device Clinical Trials (1 hour 31 minutes)
Speaker: Dr. Robert Thiel, Founder and CEO, THIEL Statistical Consultants
Description: FDAnews has a crash course in cutting-edge statistical approaches for device clinical trials, featuring an expert who can show you how to put them into use even if you have no background in statistics. Even non-statisticians can benefit from the two approaches that will be discussed. The Bayesian approach focuses on the “credible interval,” while the Frequentist approach utilizes the “confidence interval.” Each has its uses in device trial design; some situations call for Bayesian techniques, and others for Frequentist techniques. When it comes to applying statistical methods to device clinical trials, Dr. Robert Thiel of THIEL Statistical Consultants has the hands-on expertise and experience you’ll want to tap into.

Structured Product Labeling  (1 hour 8 minutes)
Speaker: Antoinette Azevedo, Founder, e-SubmissionsSolutions.com
Description: In this presentation, information management expert Antoinette Azevedo will help you choose the best, most efficient strategy for your SPL switchover. She’ll walk you through the strategic options available right now, and outline the benefits, drawbacks and timelines for each. Plus, you’ll receive a checklist to ensure successful product application submission the first time, and every time.

Reduce Human Error on the Manufacturing Floor (1 hour 15 minutes)
Speaker: Ginette Collazo Ph.D.
Description: What causes drug manufacturing failures and recalls? Human error. Time after time, CAPA investigations single it out as the root cause of violations. If there were a magic formula for ending human error, we’d share it. But here’s the next best thing — systematic best practices and strategies that have been proven to cut human error and boost success on the factory floor. This is your invitation to discover the new management science of human-error reduction in drug and biologic manufacturing.

Medical Device Supplier Audits (1 hour 19 minutes)
Speaker: Steven Niedelman, Senior Consultant, Crowell & Moring LLP
Description: To stop supplier quality problems, medical device firms must pay close attention to essential details, including receipts, bills of lading, shipping addresses, lot numbers, the number of a supplier’s personnel versus the claimed output of the facility, and much more. And above all, companies must establish efficient and rigorous supplier control and auditing programs to assure the quality of the products being used in the finished devices. FDA insider Niedelman will walk you, step by step, through the FDA’s regulations for overseeing suppliers. He’ll detail the principal ways to evaluate, audit and select potential contractors who will adhere to your compliance standards. And he’ll provide practical advice on what to include in a contract that will protect you when a supplier-related issue arises.

Change Control Forms for Medical Devices (59 minutes)
Speaker: Barbara Immel, President, Immel Resources LLC
Description: Isn’t it time you started paying more attention to the way your organization handles change control forms? Especially when mistakes can be so costly? Take a proactive step and tune in to Change Control Forms for Medical Devices to get advice and guidance from Barbara Immel, a top expert in the field with hands-on experience creating effective and compliant change control forms to validate systems … plus in-depth understanding of how to use electronic change control forms.

A World Apart: Understanding Differences in EU and U.S. Medical Device Regulations (1 hour 44 minutes)
Speakers: Cristiana Spontoni, European Partner, Squire, Sanders & Dempsey LLP and Maureen Bennett, Partner, Squire, Sanders & Dempsey LLP
Description: When you're dealing with European Union and U.S. markets that each spend more than $55 billion per year on medical devices, you want to be certain you know how the regulations differ. Failure to understand these regulations can lead to delays in approval, repeat paperwork, additional costs or worse, outright denial of market access. Here’s your chance to learn how to successfully file for device approval in both the EU and the U.S. and how they differ.

REMS Pitfalls and Challenges (1 hour 30 minutes)
Speaker: Edward Fotsch M.D., CEO, PDR Network LLC
Description: The FDA’s new REMS rules have sown confusion in the industry. Do you understand the difficult task of how to create a REMS? The goal of this webinar: To help you make sense of complex new FDA rules and avoid stepping over lines, both visible ... and hidden. It’s a dive in the deep end to identify and avoid pitfalls in REMS development … put together communications plans that work … and integrate REMS programs with emerging electronic health record (EHR) systems.

Off-Label Promotion (1 hour 37 minutes)
Speaker: Alan Minsk, Chair of the Food and Drug Practice Team, Arnall Golden Gregory
Description: The FDA off-label crackdown may even include misdemeanor prosecutions for individual drug and device executives. Don’t risk a criminal record for doing your job! Drug and device execs: Be warned. Not only could your company be subject to warning letters for violating off-label promotion standards ... but you could be criminally prosecuted for misdemeanor violations. There’s no time to waste. You must get up to speed right away on new get-tough standards — what you can do, what you can’t, and how to avoid landing in the hottest water of your professional life. A top lawyer, Alan Minsk, walks you through the agency’s fast-changing enforcement policies and standards.

Writing and Enforcing Effective SOPs (58 minutes)
Speaker: Annalisa Pizzarello, Head of Global Compliance, Amgen
Description: One of the top causes of FDA citations is the failure to establish and follow adequate standard operating procedures (SOPs). But it doesn’t have to be that way. Learn best practices in how to write SOPs and train your staff to follow them. In this webinar, expert Annalisa Pizzarello walks you through some of the basic guidelines for making sure your company effectively documents its processes and consistently follows them, helping you to avoid regulatory action and increase efficiency.

Analytical Method Validation Crash Course (1 hour 18 minutes)
Speaker: Melissa Smith, Co-chair, PDA Task Force for Method Development and Qualification
Description: By failing to heed analytical method validation guidelines, companies today risk millions of dollars in losses from noncompliance delays. Don’t be among them. Sign up now for this intensive “total immersion” webinar. It’s an intensive webinar, designed for everyone in your organization with quality and validation responsibilities, featuring a well-known session leader who can impart the basics in a quick-paced 90 minutes.

Clinical Trial Inspections (1 hour 32 minutes)
Speaker: David Rosen, Partner, Foley & Lardner
Description: Always a challenge, FDA clinical trials inspections today are more trying than ever. But you can tap into the thinking of FDA inspectors — with the help of a former FDA insider. Clinical trial inspections are changing as the FDA shifts focus. In the past, you never knew what to expect when an FDA inspector knocked on your door — and today, things are even more confusing. For example, the agency now requests third-party audits of representative samples from sites. And you can expect rejection of data, warning letters and follow-up inspections if your monitoring is deemed inadequate or your SOPs don’t pass muster. Is your documentation adequate? Do your GCP processes meet FDA standards? What will the investigators find, once they have pulled out their clipboards? Take action before that next inspection. Discover the simple steps you can take now to ease inspection anxiety and get on the right path.

New 'Tag-Along' Part 11 Inspections (1 hour 29 minutes)
Speaker: Gordon Richman, Vice President, Strategic Compliance Consulting and General Counsel, EduQuest
Description: As CDER adds electronic systems audits to routine quality inspections, what are your biggest vulnerabilities — and best protections — against enforcement actions? To help you spot and fix your own most glaring vulnerabilities, Mr. Richman clears away myths and misunderstandings that have already triggered FDA warning letters. He’ll arm you with a common-sense approach to understanding CDER’s expectations and integrating Part 11 compliance into every aspect of quality management.

Process Validation for Medical Devices (1 hour 24 minutes)
Speaker: Mike Long
Description: Are you in compliance with process validation rules? If you answered “no,” you’re not alone. Even if you answered yes, you might not really be. In recent years, countless medical device manufacturers have dragged their heels — but they’re not getting away with it now. Are you willing to risk regulatory sanctions — or worse, product recalls that could cost millions of dollars? Or are you ready to take the next step and achieve mastery of this complex, technical but vital area? Here’s the easy way — a webinar that gets you up to speed in just 90 information-packed minutes.

Spreadsheet Validation (1 hour 40 minutes)
Speaker: David Harrison, Principal Consultant, ABB Engineering Services
Description: What if you could perch on the shoulder of an expert on spreadsheet validation ... look on in real time as he posts entries and manipulates cells ... ask why he does this instead of that — and get feedback? What if you could discover the tips and tricks that will help you streamline your spreadsheet validation process for quick-and-final FDA approval? Well, you can. Step by step, Mr. Harrison will walk you through his own spreadsheet to demonstrate what functionality needs to be validated and what security controls need to be put into place.

Federal Pharma and Device Physician Gift Law (1 hour 25 minutes)
Speaker: John Patrick Oroho, Principal, Porzio, Bromberg & Newman P.C.
Description: Today, your challenge is to use gifts to build relationships without violating the Federal Physician Payment Sunshine provision. You’ll need expert guidance — because there’s not always a black-and-white answer as to what’s okay and what isn’t. Mr. Oroho will clarify what the federal law now requires and how to mesh these requirements with existing state requirements. He will leave no stone unturned in showing you how to protect yourself.

Direct-To-Consumer Broadcast Ads (43 minutes)
Speakers: Dara Katcher Levy, Attorney, Hyman, Phelps & McNamara P.C. and Carrie Martin, Associate, Hyman, Phelps & McNamara P.C.
Description: In this presentation, two top lawyers who specialize in drug marketing compliance will conduct a show-and-tell of drug ad no-no’s under the proposed DTC rule. They’ve created mock DTC ad soundtracks they’ll share with seminar participants. Misleading language is only a part of what you’ll discover. Did you know that potential violations also may include soundtrack volume ... speed of vocal delivery ... even distractions in the visual background? You’ll study prior DDMAC warning letters that use language similar to that in the proposed rule, to show what the FDA is looking for. You’ll discover what “flexible” enforcement means — and situations where the agency is not likely to be flexible.

Emergency Planning Under the New FDA Guidance (1 hour 9 minutes)
Speaker: John C. “Jack” Garvey, Founder, Compliance Architects
Description: In January 2010, the FDA released a draft guidance that requires manufacturers of medically necessary drug products (MNPs) to have specific emergency plans — and corresponding SOPs — for each of their facilities in case of disasters and resultant high absenteeism. This webinar will “decompose” this difficult draft guidance, explain what it says (and what is doesn’t), identify red flags within it, and provide recommendations on what steps your company should be taking TODAY to meet its likely requirements.

Assuring GLP Compliance (1 hour 46 minutes)
Speaker: Chitra Edwin Ph.D RAC, Principal, Biotechnology Consulting Solutions
Description: Noncompliant lab practices can cost far more than the wrath of the FDA. Improper lab work can also torpedo an investigational new drug (IND) appliation, at a cost of years of work down the drain. Could this happen at your facility? If you think there’s even a remote chance, it’s time for a refresher course. You’ll learn strategies to help streamline, organize and reinforce the importance of FDA and ICH regulatory rules governing GLPs during preclinical and Phase 1 IND development. You’ll also discover proven guidelines for the successful setup and management of every component of a regulated compliant laboratory.

Medical Device Supplier Quality (1 hour 43 minutes)
Speaker: Dan O’Leary, President, Ombu Enterprises LLC
Description: In an era of the global supply chain, supplier quality agreements are critical legal documents that are increasingly becoming required by regulatory agencies worldwide. Here’s expert advice on how to craft agreements that will meet requirements — and protect you. Make sure your agreements provide all the protection you need. Join industry expert Dan O’Leary for this presentation.

Falsified Data in Clinical Trials (1 hour 28 minutes)
Speakers: David Clissold, Director, Hyman, Phelps & McNamara and Nisha Shah, Associate, Hyman, Phelps & McNamara
Description: Is the FDA about to name you their fraud police? A proposed new rule will require sponsors to report data falsifications … without any proof … without a possible motive … and even if there’s only a suspicion of fraud. The FDA sent shockwaves through the industry on Feb. 19 when it announced a proposed rule called “Reporting Information Regarding Falsification of Data.” The rule will require sponsors to report any information that indicates that a person has, or may have, engaged in the falsification of data involving clinical investigations, nonclinical laboratory studies and clinical studies in animals. What exactly is going on here? Is the FDA trying to turn sponsors into detective, judge and jury? Learn more about this controversial proposal in this presentation.

How to Write and Maintain Bulletproof Company Core Data Sheets (1 hour 17 minutes)
Speaker: Alan Hassell, Independent Consultant
Description: Does your CCDS measure up to U.S., EU and global standards? Determining what information should — or shouldn't — be in your CCDSs is unclear. Including too much information can raise unnecessary red flags; with too little information, important safety signals or regulatory requirements can be missed. How can you be sure it meets FDA and EMA standards to track safety data so you can use it for their required filings? Join pharmaceutical consultant Alan Hassell to be certain your CCDS is well-written.

eCTD Regulatory Strategy and Product Lifecycle (1 hour 20 minutes)
Speaker: Gina Ross, Manager of the Regulatory Publishing Department, Beckloff Associates Inc.
Description: An eCTD filing is all about using metadata properly and making sure you have the necessary granularity in your documentation.  Many changes happen during each product’s lifecycle, and unless you are organized correctly the first time, it could be back to the drawing board for you. To be successful, you need to do serious advance planning to your authoring practices and organize content the right way. This FDAnews webinar will show you how to create a content development and organization strategy and how to write authoring SOPs that jibe with your global regulation strategy. 

cGMPs From An Auditor's Perspective (1 hour 9 minutes)
Speaker: Robert Schiff Ph.D., CEO, Schiff & Company
Description: How will your next FDA inspection go? What will the investigator look for in your operation? A re-energized FDA has been hiring and training hundreds of additional investigators. Now they are fanning out into the field. Next thing you know, one of them will be knocking on your door. What are their marching orders? Where will these recent recruits start poking around first, looking for soft spots in your manufacturing operation? Dr. Robert Schiff makes it his business to stay a step ahead of the FDA. A certified quality auditor and fellow of the Regulatory Affairs Professional Society, he’s the next best thing to being a “fly on the wall” inside FDA’s investigator training classes.

International Drug and Device Recalls (1 hour 19 minutes)
Speaker: James M. Wood, Attorney, Reed Smith
Description: Isn’t it about time you developed a proactive international recall strategy? This webinar shows you how to craft a master global recall strategy to protect your product from the toughest regulatory storms, at home and abroad — solidly based upon the regulations of the FDA, World Health Organization, European Medicines Agency and the Health Protection Branch of Health Canada.

QSR Data and Trending (57 minutes)
Speaker: James Eric Miller, Core Quality Systems Senior Quality Analyst, Roche Diagnostics
Description: An overlooked requirement within the Quality System Regulation (QSR) is quickly moving up the audit checklist of FDA investigators. QSR Section 820 doesn’t mention the word “trend,” but the FDA has demonstrated in 483s and warning letters that it expects companies to analyze and trend their quality data — and then act on what they’ve learned. Maybe you’ve already mobilized but need to fully understand the scope of the QSR. Or you’re unsure where to start, and want a playbook on setting up a quality and data trending system. You know the sooner you do, the more stable and useful your information will be — substantially improving your odds of passing the FDA’s new QSR audit challenge.

Cleaning Validation Risks (1 hour 38 minutes)
Speaker: Rich Yeaton, President, East Coast Validation Services LLC
Description: Your manufacturing equipment may be clean, but is it FDA-clean? Thousands of drug doses or devices may be at risk if your equipment isn’t properly validated for cleanliness. This webinar shows you how to get it right. With more than two decades of experience, your webinar expert Rich Yeaton has worked with everyone from Merck to Genzyme to DuPont, and he reveals the front-line cleaning validation techniques you need to stay FDA‑compliant.

Serious Adverse Event Reporting for OTCs and Dietary Supplements (1 hour 33 minutes)
Speaker: Ivan Wasserman, Partner, Manatt Phelps & Phillips LLP
Description: Adverse event reporting used to be something for the name brand manufacturers to worry about. Not anymore. Now the FDA is slapping the same rules on OTC and supplement makers. OTC and dietary supplement regulations expert Ivan Wasserman walks you through the new regulations ... the FDA’s guidances on the matter ... and what changes you need to implement now. Perhaps most important, he’ll spell out compliance strategies — how the FDA is likely to enforce these rules, based on actual past experience and agency comments.

Adverse Event Compliance in Drug and Biologic Clinical Trials (1 hour 21 minutes)
Speaker: Charles H. Pierce MD, PhD, FCP, CPI, Pierce One Consulting
Description: Clinical investigators face tough new regulatory filing requirements by the NIH ClinicalTrials.gov registry … beefed-up requirements for filings with EMEA’s EudraVigilance system … and for OTC drugs, copies of the label must be included with adverse event reports. As a result, many research facilities are now drowning in adverse event data without knowing where or how to report it. Rules vary depending on who is doing the reporting (investigator, sponsor or IRB), and to whom — investigator, sponsor, IRB, the FDA or OHRP. It’s time for you to take a fresh look at adverse event compliance – before you get a warning letter, a fine ... or worse.

GLP Compliance (1 hour 26 minutes)
Speaker: Chitra Edwin PhD RAC, Principal, Biotechnology Consulting Solutions Ltd.
Description: Success depends on learning the 10 steps to prepare for the dreaded GLP audit — the 10 key elements inspectors look for — then following them to the letter. Do you know what they are? Here’s the course you’ve been looking for — the training session that instills test-lab personnel, from old hands to new hires, with a zero-tolerance mindset that results in clean audits every time.

Form 483 and Warning Letter Responses (1 hour 28 minutes)
Speaker: Dr. Marla Phillips, Director of Med-XU, Xavier University Leadership Center
Description: The FDA got a lot tougher on Sept. 15 when it implemented a new Form 483 response program. Big players are getting snared already. But you can sidestep the FDA’s net — with secrets of crafting response letters that work.