FDA Inspection Readiness
Cost – Current GMP Client - $700; Non-Current GMP
Client - $1000; UNPA Member - $900
About This Course
This course provides attendees the tools necessary to successfully manage an inspection by the FDA. The implementation deadlines for 21 CFR 111 have passed, and the FDA is actively auditing dietary all sizes of companies involved in the manufacturing, packaging, labeling, holding and distributing of dietary supplements. Establishing a good reputation with the FDA takes a long time, and only one negative inspection can seriously damage that reputation. Ensuring the most positive outcome for your cGMP inspection requires careful planning and preparation well before it occurs, successful management of many issues during the inspection itself, and thorough follow-up after the inspection.
This course provides real-world examples and utilizes classroom exercises that will take each participant through the different phases of an FDA audit, demonstrating tools and techniques for successfully managing an inspection.