No Need to Fear FDA Inspections!
What if you had a simple, inexpensive “silver bullet”
that protects you against FDA inspection failures?

Introducing Inspection Navigator from FDAnews.
It guarantees you always meet FDA compliance requirements.

Drug Version

Device Version

While FDA inspections are a way of life, fear of failing them needn’t be. In fact, if you, your employees and facilities are in full compliance, FDA inspections should be just another day at the office — and that’s the way it can be.

The new Inspection Navigator Reference and Training Tool provides a treasury of detail on FDA compliance regulations, as well as wisdom and insider insights into best practices for managing — and passing — your inspections. Best of all, this vast library of reference materials and training materials provides resources for every member of your management team at all compliance levels.

Trust this compliance guide, and you will handily satisfy FDA inspectors.

Why risk wasted time and costly delays responding to Form 483s?

While FDA inspections can be complex and tricky — especially given the recent inspectorate reorganization — they are also eminently manageable if you have proper guidance.

Given the high cost of responding to FDA inspection violations — which can add up to months of bureaucratic red tape — it’s far easier and cheaper simply to make sure you’re in compliance. That’s why it makes sense for so many pharmaceutical or medical device companies to trust the Inspection Navigator to keep staff informed and trained on current protocols.

This single multimedia library covers the entire FDA inspection process —
so you’re confidently ready for anything

In a lively variety of webinars, eLearning courses, special reports, books, articles and videos, the Inspection Navigator gives your staff safe, proven responses to virtually all FDA inspectors’ queries and requests — including those regarding employee training requirements.

This comprehensive reference and training tool helps you calmly handle all elements of FDA inspections, by mastering critical skills such as these:

  • Best and worst inspection practices
  • Understanding the FDA’s new inspection process
  • Preparing your facility for inspection
  • Preparing your employees for an inspection
  • Basic and advanced training for subject matter experts
  • Surviving a regulatory interview in the facility
  • Surviving a surprise regulatory review
  • How to create an inspection response team
  • Key elements of every inspection war room
  • Creating your investigations operations manual

Drug Version

Device Version

Get inspection survival advice from leading FDA and industry experts

When you use the Inspection Navigator to prepare your team, you know you’re getting inside insights. For example, you’ll receive exclusive videos of renowned FDA inspection experts, who give their studied recommendations on problems like these:

  • Former FDA Investigators Tell All — 10 Best and Worst Things to Do, featuring a panel of FDA inspection veterans, led by former FDA Office of Enforcement Director David Elder
  • Best Practices in FDA 483 and Warning Letter Management and Recovery, a panel discussion led by Elaine Messa of NSF Health Sciences
  • A Day in the Life of FDA’s Field Investigators, featuring a panel of current FDAers led by Lori Lawless of the Baltimore District Office
  • Program Alignment and FDA Operations, a presentation by FDA Deputy Commissioner for Global Regulatory Operations and Policy Howard Sklamberg

Train your team with the very best: Give them access to these inspection preparation experts

If you want to be sure you’re giving your people the most accurate, savvy preparation for FDA inspections, call on the industry’s top authorities. Inspection Navigator includes webinars — PowerPoints and audio lecture — on these critical issues by just such renowned experts:

  • Preparing for an FDA Inspection, by John Avellanet of Cerulean Associates, LLC
  • Digging for Gold: How to Mine FDA’s Inspection Reports by attorney and FDA regulatory expert Michael Swit of Duane Morris
  • FDA’s New Inspection Approach by Kelly Thomas and Rich Yeaton of Atlantic Technical and Validation Services
  • FDA’s New Inspectorate Reorganization by consultant Joann Cochran
  • Delaying, Denying, Limiting, Refusing Inspection by Lynn Tyler of Barnes & Thornburg, LLP

Drug Version

Device Version

Eliminate doubt: You’ll have essential regulatory documents at your fingertips.

Inspection Navigator gives you the compliance requirements you’ll need to ensure that you fully understand what the inspector is looking for … and that you’re fully prepared. Here are just some of the documents you’ll receive:

  • Federal regulations governing quality manufacturing
  • Title 21 Code of Federal Regulations Part 211 — Current Good Manufacturing Practice for Finished Pharmaceuticals
  • FDA’s plan to change the way it conducts inspections
  • No surprises: An array of samples of all the likely FDA inspection forms you’re likely to encounter

Inspection Navigator: An extraordinary investment at an extraordinary price

Consider that by helping you avoid FDA compliance violations, the Inspection Navigator can save your company months of time and tens, even hundreds of thousands of dollars in compliance corrections.

Consider also that these materials have a list-price value of more than $10,000:

The Drug Version contains:

  • 4 eLearning courses
    • What to Expect When You’re Inspected
    • Surprise! Regulatory Inspection Today
    • Surviving a Regulatory Interview
    • Surviving a Regulatory Interview: In the Facility
  • 8 expert instructional videos
  • 6 expert instruction webinars
  • 3 special inspection survival-guide FDAnews reports
    • Investigations Operations Manual (FDA)
    • Surviving an FDA Inspection
    • Preparing for the EU GMP Inspection
  • 19 practical inspection FDAnews guide articles
    • Will You Be Ready for Your Next GMP Inspection?
    • 8 Things You Must Address in Your FDA Inspection Policy
    • Train Personnel for Inspection Interviews: Simulations
    • How to Select Your Subject Matters Experts (SME)
    • Train SMEs for Inspection Interviews: Types of Questions
    • Mock Audits Help Prepare for a Regulatory Inspection
    • How to Create an FDA Inspection War Room
    • How to Create an Inspection Response Team
    • How to Perform a Pre-Inspection Compliance Audit
    • 483s and EIRs: What They Are and What They Mean
    • Responding to 483s
    • Responding to Concerns Raised During Inspections
    • Responding to Record Requests
    • Drug GMP Inspections: Common Deficiencies
    • Can You Refuse to Let Investigators Take Photographs?
    • Can You Refuse to Let Investigators Take Samples?
    • The Keys to Effective SME Interviews
    • Deciding Whether to Let Investigators into Your Facility
    • How the FDA Inspection Process Works

The Device Version contains:

  • 4 eLearning courses
    • What to Expect When You’re Inspected
    • Surviving a Regulatory Interview
    • Surviving a Regulatory Interview: In the Facility
    • Surprise! Regulatory Inspection Today
  • 7 expert instructional videos
  • 8 expert instruction webinars
  • 6 special inspection survival-guide FDAnews reports
    • Investigations Operations Manual
    • Use QSIT to Your Advantage in FDA Device Inspections
    • Medical Device Inspections Guide
    • Guide to FDA Medical Device Regulations
    • Effective Internal Audits and Quality Control Units for Devicemakers
    • Device Supplier Controls: Avoiding an FDA Form 483
  • 22 practical inspection FDAnews guide articles
    • Creating an inspection policy
    • Preparing the facility for inspection
    • Preparing Subject Matter Experts
    • Mock audits and interviews
    • Best and worst inspection practices
    • The four different types of QSIT inspections
    • Responding to 483s
    • How to create an FDA inspection war room
    • How to create an inspection response team
    • How to perform a pre-inspection compliance audit
    • And more

Plus, you’ll never miss an update — as new developments occur with the FDA’s new inspection protocol the Inspection Navigator will send you an article detailing how the changes could affect you.

Finally, consider that you can add this protection to your company and your employee team — the entire Inspection Navigator — for only $1,697. However, if you order it now, before December 31, 2015, you will receive a $200 discount and pay only $1,497.

Drug Version

Device Version

You must be satisfied with this high-level training package — or your money back

Not satisfied with this training package? Simply, notify FDAnews within seven days of receipt of Inspection Navigator and return the electronic thumb-drive copy, and we will refund 100 percent of your purchase price.

To order or for more information, phone toll free: (888) 838-5578