FDA: missions, regulations, getting ready to pass an inspection

Consequences of failing a FDA investigation could be so catastrophic that the announcement of a FDA inspection induces an important stress in a company. Knowing the FDA, its role, its mission and the way of thinking of investigators and compliance officers allow being better prepared and viewing these inspections with equanimity. To pass a FDA inspection very often hangs by a thread. A big part of the problem being how to know what is important, what to tell them, what not to tell them, how to answer to an observation, what to show them … With a practical approach, this training course prepares you to manage your relationship with FDA.

 Obtain all elements to understand FDA organization.

 Understand the principles behind cGMPs and their continuous evolution.

 Know regulatory requirements and Industry approach and practices regarding cGMPs.

 Better understand FDA structure (ORA/CBER/CDER/CDRH/…) and its objectives.

 Know the cultural differences between Europe and United States and their effect on investigations.

 Know how to manage a FDA inspection before, during, and after (Front room, Back Room …).

 Know how to efficiently communicate with FDA (« Dos » and « Don’ts »).

 Understand why FDA always raises the stakes.

 Discover current and new subjects (« hot topics ») and anticipate on FDA future evolutions.

1. Definitions and objectives of FDA

Position and importance of the FDA Agency. Introduction to FDA. FDA, its mission, its role and its approach of the industry. FDA History. Who is inspected by FDA? Notions of Product Safe, Pure and Efficient.

2. FDA Regulations and Guides

FDA and its organizations: (CBER, CDER, CVM, CFSAN, CDRH, NCTR and ORA). 21CFR: Preamble, Subparts (21CFR 210/211, 21CFR 820 …), FDA Guidance’s, FDA Inspection Guides, FDA Compliance Programs, FDA Policy Statements, Other Publications, Advisory Opinions. What is an « adultered » product and what are the consequences to have a product considered adultered? FDA Investigation Operation Manual: Content and importance. How to find the right information, and under-stand what is explicit and implicit in 21CFR’s? How to find more information? How the Law becomes the Law?

3. Consequences and cost of a FDA submission

FDA – Freedom of Information Act – The Right to know. Consequences and « cost » of a FDA inspection. Batch recall and « MedWatch ». Classical excuses! 483 and Warning Letters.s

4. Differences between European Inspections and American Investigations
482, 483, EIR, Warning Letter? Different types of FDA inspections: PAI, QSIT, « Risk-Based » Differences regarding foreign inspections. cGMP and FDA: Concept of Progress. Differences between FDA and European approaches and consequences of these differences. Cultural differences between USA and Europe: Why something could be considered as minor by an European inspector and critical by an American investigator?

5. How to prepare your company for the future regarding what is now important for industry

A brief review of “Hot Topics” (counterfeit, Risk based approach, Drugs “on line», terrorism impact, Critical Path, PAT) . Risk-Based Approach – What? Why? How? Where is it coming from? Why now?
FDA – The cost of Quality. Good Documentation Practices according to FDA.

6. The course of a FDA inspection. How to be prepared, proactive, professional?

Managing FDA inspections (before, during, after) What will be inspected? What to do before inspections? What the inspectors can do and cannot do? Front room et Back room: For which purpose and how to manage them? DOs & DON’Ts during inspection. What to do when you are confronted to a hypothetical question? What to do when you are confronted to a quantitative question? Ambiguous words not to use. Following a Warning Letter / 483 – What to do?

PRACTICAL CASE STUDY

Several case studies are proposed:

 Analysis of “actual” inspector notes following an inspection: What is it wrong with the answers? What would you have done or said? Which answer would you propose to avoid having problems?
 Analysis of “actual” observations extracted from 483: What is the problem? How could you have avoided it? What would you answer?
 Analysis of “actual” observations extracted from Warning Letters: What is the problem? How could you have avoided it? What would you answer?

A Multiple Choices Questionnaire is proposed at the end of the training session in order to evaluate the acquired knowledge.