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 need to know and what you should do to survive an FDA inspection with the least possible pain.

Topics: FDA inspection seminar, FDA inspection, FDA 483, FDA warning letter, FDA investigator, FDA law, Regulatory Sanctions used by FDA, Prohibited Acts, Management Responsibility from FDA’s view, FDA Inspection Team, FDA Inspection SOP, FDA Meeting, FDA inspection Scribes, Warning Letter Responses, import alerts, inspection documentation