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

    Quantity   1 - 99     100 - 249     250 - 499     500 - 999     1000+  
    Price $19.90 $19.80 $19.70 $15.90 $12.90

    Quantity   


    Upgrade your order or view other GMP Products that you may be interested in:

    Banner-Monthly-200811-1-266
    8-Hour GMP QMS Webinar Training

    Calendar:

    • December 28, 2020
    • 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)

    Quantity
    example: 211, ISBN, Drug, GMP, Etc. - Press Enter
    GMP Training Mix and Match Clinical Manufacturing Handbook End of Year Special Featured Publication GCP Device GMP GCP-DRUG Featured Publication
    • Guaranteed Lowest Price
    • Quantity Discounts Available
    • Always Current, Up-To-Date
    • Company Logos Available
    • Special Customizations
    • Pocket-sized 3.75" x 6.25"
    • Prep for FDA & Client Audits
    • Employee Training & Reference
    • Promotional "giveaways"
    • Tradeshows and meetings

    Our Valued Clients










    Return to the GMP Publications home page View your shopping cart-->