Medical Device QSR

1 - Day Basic 21 CFR Part 820 Medical Device QSR GMPs

with ISO 13485 Correlations (February 2026)

This training will take into consideration 21 CFR Part 820 Training
with the basic ISO 13485 Correlations (2026) standards.

• 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)

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2 - Day QSR / 21 CFR Part 820 Medical Device Quality Management System Regulation (QMSR) with ISO 13485 Correlations (February 2026)

• Includes detailed 13485 requirements with examples.

• Includes focus on 14971 Risk Management for Medical Devices

• Considerations for Combination Devices

• Detailed requirements for 21 CFR Part 11 Electronic Records; Electronic Signatures