Pre- and Post-Approval FDA Drug Inspections

This course will explore pre-approval and post-approval drug FDA inspections. Specifically, the purpose and focus of each type of inspection will be discussed, along with the key inspectional targets of each. For pre-approval inspections, the discussion will primarily focus on the process and documentation related to demonstrating equivalence of the bio-clinical batches to the proposed commercial product. Key discussion points will include: evaluation of bio-clinical batches, raw materials, manufacturing process, finished product, and general GMP compliance. For post-approval inspections, the discussion will primarily focus on general GMP compliance issues. The various inspection outcomes for each type of inspection will also be covered. Because all FDA-regulated facilities will undoubtedly be subject to FDA inspection, it is important that employees understand what to expect and what their role should be. When this lesson is completed, the learner will be able to discuss the differences between pre- and post-approval FDA inspections, why they occur, and possible outcomes of each.

After this course learners will be able to recognize what constitutes a pre- or post-approval inspection. recognize what possible outcomes may result. identify some helpful recommendations for preparing and managing an inspection by fda.