GMP Publications - Code of Federal Regulation Handbooks by the FDA

21 CFR 11, 50, 54, 56, 312, 314, ICH E2A, E6(R2) - Good Clinical Practice Handbook

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US FDA Title 21 CFR Parts

  • Part 11 Electronic Records
  • Part 50 Protection of human subjects
  • Part 54 Financial disclosure by clinical investigators
  • Part 56 Institutional Review Boards
  • Part 312 Investigational New Drug Application
  • Part 314 Application to the FDA to Market a New Drug

    International Conference on Harmonisation Regulations

  • ICH E2A Clinical Safety Data Management
  • ICH E6 (R2) Good Clinical Practice





















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    8-Hour GMP QMS Webinar Training

    Calendar:

    • January 25, 2021
    • February 23, 2021
    • March 23, 2021
    • April 27, 2021
    • May 25, 2021
    • June 22, 2021
    • July 27, 2021

    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

    Questions and Answers

     

    Includes:
    - - Binders (shipped free for US Customers)
    - - Handbooks
    - - Certificate of Attendance (Completion)

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