Abstract

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.