Medical Device QSR

21 CFR Part 820 Medical Device QSR GMPs

• The 11 General Orders of GMP
  - Writing Procedures
  - Following Procedures
  - Good Documentation Practice
  - Validation
  - Design/Build Facilities
  - Maintain Facilities
  - Training, Education and Experience
  - Sanitation and Housekeeping
  - Control for Quality
  - Audit for Compliance
  - Prepare for Battle - Recall/Traceability

• The Quality Management System,

  • CAPA,

  • Compliant,

  • Deviation,

  • Nonconformance,

  • OOS/OOT

  • Change Control

• Design Controls, Inputs and Outputs

• Purchasing Controls

• Identification and Traceability (11th General Order explained)

• Production and process controls

• Inspection, measuring, and test equipment

• Process validation

• Acceptance Activities

• Receiving, in-process, and finished device acceptance

• Acceptance status

• Device labeling and packaging

• Handling, Storage, and Distribution

• Installation

• Records - Device Master Record (DMR)

• Records - Device History Record (DHR)

• Records - Design History File (DHF)

• Records - Quality System Record

• Records - Complaint files

• Servicing

• Statistical Techniques

• 21 CFR Part 803 Medical Device Reporting

• 21 CFR Part 810 Medical Device Recall Authority

• 21 CFR Part 830 Unique Device Identification

• 21 CFR Part 11 Electronic Records; Electronic Signatures (The Basics)