Medical Device Quality Systems Manual with 11, 820, QSR Audit Checklist, 7382.845 with QSIT

The GMP Quality Management System Regulations address issues including:
- Recordkeeping,
- Personnel Qualifications,
- Sanitation,
- Cleanliness,
- Facility Management
- Equipment
- Verification,
- Process Validation,
- Complaint Handling,
- Recalls,
- CAPA, and
- Device Reporting
and much more...

This is a great training and information tool to provide all employees with the CFR requirements for the Food, Drug, Medical Device, Cosmetic, Healthcare, Electronic Records and Good Laboratory Practice.

FDA Title 21 CFR Parts and Guidance
- 21 CFR Part 11 - Electronic Records/Electronic Signatures (ERES) with Scope and Application
- 21 CFR Part 820 - Quality Systems Regulations
- QSR Audit Checklist
- Medical Device Quality Systems Manual
- Quality System Regulation Auditor's Self Assessment Check List
- QSIT - Quality Systems Inspection Techniques
- US FDA 7382.845 - Inspection of Medical Device Manufacturers