GMP Publications - Code of Federal Regulation Handbooks by the FDA

In Vitro Diagnostics Master Handbook

In-VitroDiagnosticMaster
978-1-935131-59-5

Over 500 pages of US/EU Regulations and Guidance!

US FDA Title 21 CFR Parts

Part 11 - Electronic Records, Electronic Signatures
Part 50 - Protection of Human Subjects
Part 803 - Medical Device Reporting
Part 806 - Medical Devices; Reports of Corrections and Removals
Part 809 - In Vitro Diagnostic Products for Human Use
Part 820 - Quality Systems Regulations

In Vitro Diagnostics 2017/746 Medical Devices

Guidance for Industry and FDA Staff - In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions - June 25, 2010

In Vitro Diagnostic Devices: Guidance for the Preparation of 510(k) Submissions - HHS Publication FDA 97-4224











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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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