Inspection Readiness - FDAnews

Inspection Readiness

Foolproof Methods for Validation ? 2013

From the Editors of

The Executive Briefing Series

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Inspection Readiness:

A Guide to Preparing Subject Matter Experts to Face the FDA

Table of Contents

Introduction Facts About FDA Investigators..............................................................................................................3 Preparation--Selecting and Training SMEs...........................................................................................4 Practice--Simulating Investigator Interviews........................................................................................8 Case Study #1: Setting Up the Team....................................................................................................10 Case Study #2: Reviewing Support Processes......................................................................................13 Case Study #3: Setting the Stage..........................................................................................................15 Case Study #4: Responding to Validation Concerns............................................................................21 Lessons Learned....................................................................................................................................26 Conclusion............................................................................................................................................27 Appendix A: Answer Key

About the Author

Julie Larsen is the director of inspection readiness services at BioTeknica, Inc. Larsen, a certified quality manager, has more than 20 years of experience with quality assurance and compliance in manufacturing, division and corporate roles in medical device and pharmaceutical industries (17 years' leadership experience in quality operations and compliance at Abbott). She has extensive experience with strategy, coordination and management of FDA inspections and remediation of quality systems for compliance improvement as well as successfully addressing consent decree, warning letter and 483 responses.

Introduction

FDA investigators are knocking at your door--are you ready? Your first thoughts may be of logistics--meeting space, document availability, the condition of your facility--but what about personnel? Are your employees prepared to face FDA investigators who are trained to thoroughly investigate a manufacturer's entire operation?

The employees that know the most about your front-line operations are usually the ones who have the least experience with inspections and therefore are more likely to slip up. That's why training of subject matter experts (SME) deserves at least as much attention in your inspection readiness plan as more tangible aspects like documentation and equipment function.

Putting unprepared SMEs in the same room as trained FDA investigators who are there to interrogate and interview them is clearly not a good strategy. No matter how intelligent, well-educated and capable your people are, they can slip up and lead investigators through doors you might prefer to keep closed. FDA investigators can draw conclusions from what your SMEs say, what they don't say, even the way they do or don't say it. The best way to guarantee those conclusions reflect positively on your business is to prepare your staff for their moment in the spotlight and make sure they practice, practice, practice.

This report offers guidance on developing an SME training plan, including selecting the best personnel to participate, assessing vulnerabilities and strengths, understanding common FDA interrogation techniques and testing readiness with simulated inspection interviews.

Inspection Readiness: A Guide to Preparing Subject Matter Experts to Face the FDA

Facts About FDA Investigators

It's as important to understand how the FDA investigators operate as it is to understand what systems they'll review, the techniques they use, the cues they look for in interviews, and how they prepare for the inspection, their mindset and motivation.

The first day on the job, FDA investigators take an oath of allegiance to the U.S. government and swear to uphold the Federal Food, Drug, and Cosmetic Act. They are officers of the government, just like an FBI agent or a U.S. marshal, and they take their jobs just as seriously.

FDA investigators serve as industry watchdogs--their goal is to protect the health of all people living in the U.S. They understand that they have a great responsibility to make sure that products are safe, effective and do not adversely affect the public. They understand that there is an implicit trust that the public places in the FDA and its investigators to ensure that every product says what it does and does what it says--every time. Investigators provide the FDA with reliable data from regulated manufacturers. In turn this information allows the agency to make decisions regarding the proper use of products for the public. It's about safety; it's about people's lives.

FDA investigators are very competent. They make sure that industry is compliant with regulations. They are highly educated and trained, not only in the tenets of good manufacturing practice but also in techniques for interviewing and eliciting information from individuals. They are motivated and extremely experienced in ferreting out trouble spots and violations.

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