GMP Publications - Code of Federal Regulation Handbooks by the FDA

Title 21 CFR Parts 1 - End Nine Volume Set


978-1-935131-51-9

2020 - Nine Volume Set $475.00 Total
Food and Drug Title 21 Code of Federal Regulations

ORDER TODAY Your Complete Set - A Must Have For Your Library
Full Size 5.75 x 8.5 Exact Reprint of the Just Released 2020 CFRs
 

The Code of Federal Regulations Title 21 contains the codified Federal laws and regulations that are in effect as of the date of the publication pertaining to food and drugs, both legal pharmaceuticals and illegal drugs.
Title 21 - Nine Volume Set

Volume 1: Parts 1 - 99 SUBCHAPTER A - GENERAL
Volume 2: Parts 100 - 169 SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION
Volume 3: Parts 170 - 199 SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION (Continued)
Volume 4: Parts 200 - 299 SUBCHAPTER C - DRUGS: GENERAL
Volume 5: Parts 300 - 499 SUBCHAPTER D - DRUGS FOR HUMAN USE
Volume 6: Parts 500 - 599 SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
Volume 7: Parts 600 - 799 SUBCHAPTER F - BIOLOGICS & SUBCHAPTER G - COSMETICS
Volume 8: Parts 800 - 1,299 SUBCHAPTER H - MEDICAL DEVICES
SUBCHAPTER I - MAMMOGRAPHY QUALITY STANDARDS ACT
SUBCHAPTER J - RADIOLOGICAL HEALTH
SUBCHAPTER K - TOBACCO PRODUCTS
SUBCHAPTER L - REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION
Volume 9: Parts 1,300 - End CHAPTER II - DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 


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  • January 25, 2021
  • February 23, 2021
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  • April 27, 2021
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GMP QMS 101 The Basics - The required GMP Training for all employees who operate under Title 21 Compliance Requirements.

  • GMP - What is cGMP and the GMP Lifestyle?
  • The Agency History and Objectives
  • Roles and Responsibilities
  • The 10 Principals of GMP
  • Good Documentation Practices (GDocP)
  • Facility Management
  • The History of GMP, the Agency Inspections and 483s
  • Warning Letter Reviews

21 CFR Part 11 Electronic Records

  • 21 CFR Part 11 Basic Overview
    • 21 CFR Part 11 Definitions, System Types and Classifications
    • 21 CFR Part 11 Electronic Records; Electronic Signatures – Predicate Rule
    • Part 11.10 Sections a) - k)
    - - Validation
    - - Copies of records
    - - Protection of records
    - - Limiting system access
    - - Audit trails
    - - Operational system checks
    - - Authority checks (h) Device checks
    - - Education, Training, Experience
    - - Policies and Procedures
    - - Systems documentation
    • Scope and Application Risk Analysis - Determine Which Systems Need to be Validated
    • Steering Committee and Part 11 Initiatives

Good Auditing Practice

  • The Auditor's Basics 101 'From the Auditor's Perspective'
  • The 5 Basic Binders
  • The Quality Manual
  • IT Strategy Plan
  • Standard Operating Procedures
  • Validation Documentation
  • Drug/Device Documentation

The QMS Basics

- - CAPA
- - Non-Conformance
- - Change Control
- - Deviations
- - Out of Specifications / Out of Trend
- - Complaints
- - Recalls
- - Product Traceability
- - Audit - Internal, Agency, Customers and External Audit
- - Vendors, Suppliers, Contractors and Consultants
- - Basic Risk Management
- - Training Program

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