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Pre- and Post-Approval FDA Inspections (PHDV66)
Gain an understanding of the differences between pre- and post-approval FDA inspections in less than an hour and for under $100 with this online FDA Management training course.
Don’t let our low price for online FDA Inspections & Enforcement training fool you. These courses have all of the depth and understanding needed for certification status. Take a look at the contents of this web-based FDA Management training course before you buy to see what is covered.
This lesson explores pre- and post-approval FDA inspections. The purpose and focus of each type of inspection are discussed with the key inspectional targets. For pre-approval inspections, the discussion focuses on the process and documentation related to demonstrating equivalence of the bio-clinical batches, raw materials, manufacturing process, finished product, and general GMP compliance. For post-approval inspection, discussion focuses on general GMP compliance issues. For each type of inspection, the various inspection outcomes are also 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.
(single learner, single course)