PDA Southeast Webinar: Top Two Frequently Cited cGMP FDA Inspectional Observations for Drugs and Device

Register Now
Ask a Question

Join PDA Southeast Chapter in a virtual discussion on "Top Two Frequently Cited cGMP FDA Inspectional Observations for Drugs and Device".

This presentation will review two of the top four areas in Drugs and Devices where frequent FDA Inspection observations were cited in the past five years. For drugs, the topics of interest are investigations on unexplained discrepancies and responsibilities of Quality control unit while for devices, the focus is on corrective & preventive actions and customer complaints management. Having robust quality systems in place and implementing the regulations consistently prevents avoidable agency observations.


  • 21 CFR 211.192 – Records and Reports - Production record review
  • 21 CFR 211.22(d) – Organization and Personnel - Responsibilities of Quality control unit

    Device: Quality System Regulation

  • 21 CFR 820.100(a) – Corrective and Preventive Action
  • 21 CFR 820.198(a) – Complaint Files
Join Our Email List

More information coming soon.

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.