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Corrective and Preventive Actions (CAPA) | FDA

    https://www.fda.gov/corrective-and-preventive-actions-capa
    Important linkages regarding this CAPA element include 820.30 Design Control and 820.70 (b) Production and Process Control. 9. Verify that corrective and preventive actions for product and...

CAPA Medical Device Tracking | FDA

    https://www.fda.gov/capa-medical-device-tracking
    The purpose of the Medical Device Tracking Regulation is to ensure that manufacturers and importers of certain medical devices can expeditiously locate and remove these devices …

Case for Quality | FDA - U.S. Food and Drug Administration

    https://www.fda.gov/medical-devices/quality-and-compliance-medical-devices/case-quality

    Corrective and Preventive Action Basics - Food and …

      https://www.fda.gov/files/about%20fda/published/CDRH-Learn-Presenation--Corrective-and-Preventive-Action-Basics.pdf
      FDA Even similar devices from competitors Data Analysis Analyzeprocesses, work operations, concessions, quality audit reports, quality records, service records, …

    Medical Devices | FDA - U.S. Food and Drug Administration

      https://www.fda.gov/Medical-Devices
      Approvals and clearances, information on medical devices by type Digital Health Center of Excellence Cybersecurity, mobile medical apps, wireless medical devices, AI/ML in …

    Ultimate Guide to Corrective and Preventive …

      https://www.greenlight.guru/blog/corrective-action-and-preventive-action-capa-medical-devices
      As noted throughout this guide, CAPA is an important process for your medical device company. In fact FDA states in their QSIT guide: “One of the most …

    Medical Device Databases | FDA

      https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases
      Apr 6, 2022

    Quality System (QS) Regulation/Medical Device Good …

      https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices
      The FDA published a proposed regulation, requesting public comment, to amend the device current good manufacturing practice requirements of the Quality …

    CFR - Code of Federal Regulations Title 21 - Food and …

      https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=820.100
      The procedures shall include requirements for: (1) Analyzing processes, work operations, concessions, quality audit reports, quality records, service …

    CAPA within the Pharmaceutical Quality System

      https://www.fda.gov/media/85266/download
      CAPA is an extremely valuable tool for continuous improvement Implement risk management and focus on the important issues first As professionals we should strive to …



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