PDA Southeast Webinar: Top Two Frequently Cited cGMP FDA Inspectional Observations for Drugs and Device
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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
Location and Travel
Venue Details and Accommodations
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We're currently finalizing our list of sponsors and will share the details shortly.
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Boost your brand and visibility by becoming an exhibitor at the PDA Southeast Webinar: Top Two Frequently Cited cGMP FDA Inspectional Observations for Drugs and Device! Connect with industry influencers, showcase your products and services, and position your company as a key player in the field.
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