Understanding FDA and Avoiding Inspections Leading to Warning Letters, Seizures, Injunctions and Prosecutions January 17, 2013

Course Description:

Every company regulated by the U.S. FDA establishes procedures, practices and an internal monitoring system all designed to both meet the regulations and manage inspections. However, many are surprised by Warning letters or more serious actions. Regardless of whether your company has been on the receiving side of a regulatory action or not, this course will help you in have better Quality systems, effectively managing and responding to FDA inspections.

The first day will provide you with a better understanding of the FDA culture and the unique focus of FDA investigators during inspections. You will learn what are the observations and events that will signal to you that serious regulatory actions may follow. With prior knowledge, you can identify potentially serious deficiencies before an inspection in addition to responding quicker whenever serious issues are identified.

The key to being “inspection ready” are effective written procedures, training programs and monitoring including internal auditing. The instructor having more than 40 years of experience with FDA and the pharmaceutical industry will on the second day share his perspectives on what can be improved in these systems. If you believe that any Quality system can be improved or at least that it is important to constantly re-evaluate whether your own systems, you will benefit from attending.

Those benefiting include both those from the pharmaceutical and medical device industries. Events and observations from both industries will be used.