Master Reference Desk Set - Drug, Dietary & Medical Device

Includes:

US FDA Title 21 CFR Parts:

- Part 11 Electronic Records; Electronic Signatures
- Part 11 Scope and Application 2003
- Part 11 - Auditor's Check List
- Part 58 - Good Laboratory Practice
- Part 111 - Dietary Supplements GMPs
- Parts 210/211 Drug GMPs
- Parts 210/211 Drug GMPs - Auditor's Check List
- Part 820 Quality Management Systems Regulations QMSR 2026
- Part 820 Quality Systems Regulations (Legacy)

Guidance:

• ICH Q7 - Active Pharmaceutical Ingredients (APIs)
  - ICH Q7 - Auditor's Check List
  - ICH Q8(R2) - Pharmaceutical Development
  - ICH Q9(R1) - Quality Risk Management
  - ICH Q10 - Pharmaceutical Quality System
  - EU GMPs Chapter 1 - 9
  - Canadian GMPs Edition GUI-0001 - July 2020
  - Japanese GMPs
  - Chinese GMPs Decree 79 English

Medical Device Master Regulations

Over 900 Pages of Guidance and Regulations for the Medical Device Industry Medical Device Master Manual

US FDA Title 21 CFR Parts:

- Part 11 - Electronic Records/Electronic Signatures (ERES)
- Part 801 - Labeling - Medical Device
- Part 803 - Medical Device Reporting
- Part 806 - Reports of Corrections and Removal
- Part 807 - Establishment Regulation and Device Listing for Manufacturers
- Part 809 - In-Vitro Diagnostic Products
- Part 810 - Medical Device Recall Authority
- Part 812 - Investigational Device Exemptions
- Part 814 - Premarket Approval of Medical Device
- Part 820 - Quality Management Systems Regulations 2026
- Part 821 - Medical Device Tracking Requirements
- Part 830 - Unique Device Identification

Guidance:

• Added - 820 QMSR Checklist with ISO 13485 Reference
  - Medical Device QSIT Manual
  - PMA Premarket Approval and 510 (k) Guidance
  - Inspection of Medical Device Manufacturers 7382.850
  - EU 2017/745 Medical Device Regulation