The GMP Quality Management System Regulations address issues including:
- Personnel Qualifications,
- Facility Management
- Process Validation,
- Complaint Handling,
- CAPA, and
- Device Reporting
- and much more...
Compiled and developed by John Cuspilich, Sr. Auditor for The Auditing Group.
GMP Publications Quality Compliance Publications Helping Companies Meet and Exceed FDA and Total Quality Management Standards.
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
For persons who purchased this item, you may also be interested in: On-Site Medical Device Boot Camps!