Medical Device QSR
1-Day Curriculum
2 - Day Training - 21 CFR Part 820
Includes ISO 13485/14971
21 CFR Part 820 Medical Device QSR GMPs
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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,
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CAPA,
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Compliant,
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Deviation,
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Nonconformance,
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OOS/OOT
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Change Control
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Design Controls, Inputs and Outputs
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Purchasing Controls
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Identification and Traceability (11th General Order explained)
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Production and process controls
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Inspection, measuring, and test equipment
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Process validation
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Acceptance Activities
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Receiving, in-process, and finished device acceptance
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Acceptance status
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Device labeling and packaging
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Handling, Storage, and Distribution
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Installation
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Records - Device Master Record (DMR)
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Records - Device History Record (DHR)
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Records - Design History File (DHF)
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Records - Quality System Record
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Records - Complaint files
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Servicing
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Statistical Techniques
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21 CFR Part 803 Medical Device Reporting
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21 CFR Part 810 Medical Device Recall Authority
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21 CFR Part 830 Unique Device Identification
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21 CFR Part 11 Electronic Records; Electronic Signatures (The Basics)