During FDA regulator panels at last year’s PDA/FDA Joint Regulatory Conference and ISPE Annual Meeting, FDA regulators addressed participant questions concerning how FDA investigators evaluate a company’s GMP compliance.

Redica Systems Senior GMP Quality Expert Jerry Chapman provides extensive coverage of these two sessions in the following three articles:

• FDA Regulators Address Data Integrity and Lab Audit Trails
  How can a robust data governance plan prevent data integrity issues? And why are FDA investigators concerned about audit trails for analytical instruments? Panelists in the “Inspection-Based Panel Discussion” at the PDA/FDA Joint Regulatory Conference addressed these topics and more.
• Quality Culture Assessments and Records Request Responses
  FDA investigators are increasingly evaluating the quality culture within organizations. Plus, learn how to effectively respond to an FDA records request.
• FDA on Cross-Contamination, Sustainable Compliance, and Contract Ops
  At the 2021 ISPE Annual Meeting, FDA Commander (CDR) Tara Gooen Bizjak discussed significant emerging GMP compliance issues.

Additionally, staying on top of inspection readiness is one way to help ensure GMP compliance. Check out the video clip below for tips on preparing for your next FDA inspection.

Interested in more from Jerry Chapman? Click here to download a FREE report that includes four articles examining quality and GMP compliance within pharmaceutical manufacturing.