GMP Publications - Code of Federal Regulation Handbooks by the FDA

Medical Device Quality Systems Manual with 11, 820, QSR Audit Checklist, 7382.845 with QSIT

MedDeviceQualitySysMan.11.820.Cklist.QSIT.7382.845.jpg
QSM/QSIT

The GMP Quality Management System Regulations address issues including:
- Recordkeeping,
- Personnel Qualifications,
- Sanitation,
- Cleanliness,
- Facility Management
- Equipment
- Verification,
- Process Validation,
- Complaint Handling,
- Recalls,
- CAPA, and
- Device Reporting
and much more...

This is a great training and information tool to provide all employees with the CFR requirements for the Food, Drug, Medical Device, Cosmetic, Healthcare, Electronic Records and Good Laboratory Practice.

FDA Title 21 CFR Parts and Guidance
- 21 CFR Part 11 - Electronic Records/Electronic Signatures (ERES) with Scope and Application
- 21 CFR Part 820 - Quality Systems Regulations
- QSR Audit Checklist
- Medical Device Quality Systems Manual
- Quality System Regulation Auditor's Self Assessment Check List
- QSIT - Quality Systems Inspection Techniques
- US FDA 7382.845 - Inspection of Medical Device Manufacturers

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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)

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