FDA Enforcement and Compliance Trends

Date: April 22, 2020
Instructor: Mr. John Y. Lee
Location: Online
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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