GMP Publications - Code of Federal Regulation Handbooks by the FDA

Medical Device Quality Systems Manual with 11, 210/211, 820 and QSR Audit Checklist


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...

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.

US FDA Title 21 CFR Parts

  • Part 11 - Electronic Records/Electronic Signatures (ERES) with Scope and Application
  • Part 210/211 - cGMP in Manufacturing, Processing, Packaging or Holding of Drugs and Finished Pharmaceuticals
  • 21 CFR Part 820 - Quality Systems Regulations
    QSR Audit Checklist
  • Medical Device Quality Systems Manual
  • Quality System Regulation Auditor's Self Assessment Check List

For persons who purchased this item, you may also be interested in: GMP Auditor’s Basic Handbook




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