Monday, March 3 1:15 PM - 1:55 PM
Inspections/Regulations - Taking the Risk Out of Inspections
Preparing for an FDA inspection can be scary, but knowing what to expect will help you evaluate the strength of your food safety system and routine operations to prevent major risks to customers and brand. This session will cover the general inspection procedure, routine FDA forms, and common records reviewed. I will also cover an overview of the compliance process and tips on responding to FDA Form 483 observations.
Learn the FDA inspection process and the meaning of common forms. Understand what records are routinely covered and what types of samples FDA may take. Know how to respond to FDA observations noted after an inspection.
Participants will take away an understanding of:
The FDA inspection process and routine FDA inspection forms
The goal of an FDA inspection and common violations
Types of FDA inspections and sampling procedures
Types of records reviewed
Responding to an inspection finding and an overview of the compliance process
William Weissinger, Food and Drug Administration