FDA Enforcement and Compliance Trends


The FDA GMP regulations in 21CFR211.25(a) require the performance of GMP training “…on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements…” Pharmaceutical industry standard provides repeat GMP training to all employees at an annual frequency, at minimum, to comply with this GMP requirement.

This presentation on “FDA Enforcement and Compliance Trends” fulfills the FDA requirement for continuing CGMP training with an analysis of FDA-483 and FDA warning letter citations issued in FDA Fiscal Year (FY) 2020, to identify and review the major GMP compliance deficiencies, trends and issues. The presentation includes the following topics:

  • FDA-483 and FDA warning letter statistics and trends for FY 2020 with comparison to previous years
  • Ranking of major compliance deficiencies and warning letter citations
  • Review of FDA foreign inspection enforcement and compliance trends
  • Identification and review of major, current, recurring and novel GMP compliance issues and deficiencies; for example:
    • Data integrity
    • Deviation and OOS investigations
    • Quality unit oversight
    • Validation (process, test methods, cleaning, supplier, computer)
    • Risk assessment
    • Downstream control (testing quality into the product)
    • Supplier and contractor import alert
    • Contractors and product owner (contract giver) responsibilities
    • Smoke study validation
    • Common facilities/equipment for drug and non-drug manufacturing

Learning Objective

The attendee will gain knowledge of the latest FDA expectations and interpretations for GMP compliance to fulfill the 21CFR211.25(a) regulation to remain familiar with the GMP requirements. Attendees with responsibilities for GMP compliance and product quality will use their learnings to assess their companies’ GMP compliance profile and to implement corrective actions, if necessary, to avoid FDA regulatory actions.

Who Should Attend

This presentation is targeted for professionals and management who have direct or indirect responsibilities for supervising or assuring GMP compliance and product quality; for example, quality assurance, GMP compliance auditing, quality control laboratories and manufacturing. Professionals for raw material procurement and contactor services would benefit from the information related to the FDA’s increased compliance focus for suppliers and contractors, and the FDA’s enforcement of its import alert program.

Verified knowledge – optional post-course test!

Use our post-course test to prove that the training session was effective for you! We have put together a test with 12 multiple choice questions based on the information Mr. John Lee presents in this course. For all of you that want to use this training to show that you remain familiar with GMP requirements – your yearly re-training perhaps – this test will add value since it also gives proof of the knowledge that you have gained. Add the test to you Cart and you will receive a test instruction and a log in to our test site directly after the course.

SmartGMP® test – FDA Enforcement and Compliance Trends FY 2020 – Pharma



John Y. Lee




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