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cGMP/QSR: Interpretation and Application (Medical Devices)

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Medical device GMP requirements, as specified in 21CFR Part 820 Quality System Regulation, are general and subject to interpretation. The FDA stated that the GMP was intentionally written as such to allow the medical device industry the flexibility to apply the GMP in a manner appropriate for each specific operation. To keep pace with the rapid technological advances in the industry since the 1978 GMP revisions, the FDA has been supplementing the GMP with interpretive guides, guidelines and policy statements to keep it current and to ensure its applicability to current industry operations and practices.

This course will concentrate on the FDA's current interpretation of the GMPs with an in-depth review of the agency's regulations, guidelines, inspection guides, compliance programs, proposed rules, publications and policy statements. Each section of the GMP regulations will be reviewed along with the FDA's interpretation of that section. An integral part of this course will include discussions on the FDA's interpretation and application of current GMP with a review of pertinent inspectional observations (FDA-483) and warning letters.

  • Overview of FDA's Quality System Regulation
  • Scope and Management Controls
  • Documents, Records and Change Control, and Identification and Traceability
  • Design Control
  • Material Control
  • Production and Process Control
  • Process Validation: QSR and GHTF Guidance
  • Complaint Handling and Servicing
  • Corrective and Preventive Actions