Managing Domestic and Foreign FDA Inspections and the COVID-19 Impact

FDA inspects many different kinds of firms. If the FDA regulates your product, they can show up at your lobby and say, “I am here to conduct an inspection.” What do you do? What have you done to prepare for an inspection? How do you deal with the investigator, including their personality? The scary part is having to explain the error of your ways to the FDA and above all, managing an administrative action, e.g., Warning Letter or Import Alert, or a legal action, e.g., civil money penalties, seizure, injunction or prosecution. This course will help you with what you need to know and what you should do to survive an FDA inspection with the least possible pain.

Seminar Instructor Casper Uldriks is an "Ex-FDA Official" who has spent 32 years in FDA. He currently trains FDA personnel and counsels clients on wide range of topics, including: FDA inspections; import operations; advertising and promotion; corrective and preventive actions; medical device reporting and corporate reorganization to improve conformance to the FDA’s requirements.

He understands how FDA thinks, operates and where it is headed.

The course will cover the factors used by the FDA to schedule inspections. You will learn how to predict what an FDA investigator will do and what they will cover in the inspection. There should be no surprises if you have prepared properly. Firms need to understand the details about inspectional techniques to avoid making new problems for yourself during the inspection. You can save yourself a lot of corporate misery if you know what to do before, during and after an inspection.

FDA conducts inspections based on well established procedures. You can lower your anxiety level when you can predict what they will do during an inspection, what products they cover and how they will document your problems. Any type of regulated firm should the ground rules of an inspection to keep it under control. You should be able to see the hand writing on the wall if it looks bad and prepare accordingly. You should understand what is at stake based on the progress of an inspection. How you respond to an investigator, to the inspection in general and to the FDA can seal your fate to an unhappy ending if you don’t know what to do, how to do it and how fast you need to do it. Questions are encouraged. What did you want to know about FDA, but were always afraid to ask? What are the big mistakes firms make? Here the firsthand accounts of an ex-FDA investigator.

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