Course Agenda

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