FDA Case Scenarios: Best Practices for Managing Inspection Situations

The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if you want an inspection that results in a satisfactory report. 

Companies can prepare and train their staffs effectively for prior inspection management, but once the audit begins, certain difficult situations, requests or issues may arise that may prove hard to manage properly. 

In this 90-minute accredited course, you will hear about real life examples of inspection issues on different topics such as Opening Day, Documentation, Tours, SME situations, Safety, and Inspection team situations. We will examine what went right and how the situation may have been handled differently.

THIS TRAINING IS PART OF OUR FDA READINESS PROFESSIONAL CERTIFICATION

• To enroll into the complete FDA Readiness Professional Certification Program CLICK HERE.  This program includes 10 specific online courses for $2050.
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