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

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.

Drugs:

• 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