GMP Publications - Code of Federal Regulation Handbooks by the FDA

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

MedDeviceQualitySysMan.AuditChecklist11.210211.jpg
978-1-935131-08-3

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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