Short Abstract

This seminar will give you current excellent understanding of how FDA is working today and how assure your quality systems will meet FDA expectations.

In the areas of inspections we will explore how FDA determines which firms to inspect. What are the current driving forces for FDA inspections? What about Supply Chain issues. We will also talk about how to manage inspections in a way to minimize FDA concerns, and what to do if things are not going well during the inspection.

We will review profiles of recent warning letters related to quality systems compliance. By understanding what FDA says in their Warning Letters you can address you own quality systems in a much more focused area by knowing what FDA expects. Finally we will discuss how to respond to Warning Letter and FDA-483’s

CAPA currently is the quality system that FDA is concentrating on the most. FDA’s expectations of your CAPA program are quite high, and if you just have a basic CAPA program you may not meet FDA expectations. We will talk about the “unwritten” CAPA regulations that FDA uses inspect you.

We will end the day on a high note by talking about FDA Enforcement Actions! Seriously by understanding how FDA uses their enforcement authority you can avoid being subset to one of those FDA enforcement Actions.