Awareness of FDA Inspections for Pharmaceutical Manufacturers

This course covers the basics of FDA inspections of drug manufacturing facilities, including authority, purpose, types, and areas/operations typically inspected. The course also discusses how companies and their personnel should generally handle FDA inspections and interact effectively with Investigators. Topics in this course include: Scope, Inspection Types, Initiation, Handling Inspections, Inspection Coverage, FDA Interaction, and Closeout. After completing this course, learners will be able to identify the basics of FDA inspections of drug manufacturing facilities and how firms should handle FDA inspections and interact effectively with Investigators.