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How FDA Trains Its Investigators and Inspectors to Review Sub-Systems for State of Compliance: What You Need to Do to Prepare for a Successful Inspection – GlobalCompliancePanel

August 25, 2016 - August 26, 2016


Think like and behave like an FDA investigator and recognize your greatest risks and vulnerabilities. Your authority to enter and inspect establishments is predicated upon specific obligations to the firm per FDA’s documentation and we will review in detail. It is FDA’s responsibility to conduct all inspections at reasonable times and within reasonable limits and in a reasonable manner. FDA needs to proceed with diplomacy, tact and persuasiveness. During inspections or investigations, when FDA has evidence of conditions whereby there is a reasonable probability the associated products will cause imminent and serious adverse health consequences or death…we will address this during the seminar and what happens next.

By directing your attention to the major areas in a firm’s quality system, you should be better able to determine if the firm’s quality system is in control. Using the subsystem approach, you may find less opportunity to cite minor deviations from the quality system regulation than in the past. However, you will be citing more serious (systemic) deviations from the regulation. FDA inspections are typically the starting point for the sequence of enforcement actions, since serious violations discovered at inspections will often result in Warning Letters, which in turn, if not properly responded to, can turn into seizures, injunctions, prosecutions, or recalls or consent decrees. So you can look at the number of inspections as one indicator of how aggressive FDA is being regarding enforcement. The seminar will provide an in-depth overview of the various enforcement actions, with primary focus an emphasis on Warning Letters, Seizures, Injunctions and Prosecutions.

The Seminar will provide all details relevant to Pre- and Post-Inspectional activities, tactics, strategies and is a must for those who have never gone through an FDA inspection and as a “refresh” for those who have to ensure your “state-of-readiness” and being prepared.

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