Course Agenda (Download the Agenda) please see brochure for times.

GMP QMS 101 The Basics - The required GMP / QMS Training for all employees!

• GMP - What is cGMP and the GMP Lifestyle?
• The History of GMP, the Agency Inspections and 483s
• Warning Letter Reviews (Review of actual 483 violations and warning letters)
• The 11 General Orders or Principals of GMP
  • Writing Procedures (with template examples)
  • Following Procedures (and the failures that occur)
  • Documentation (Rationale, Requirements and the Regulations)
  • Validation (Concepts, and basic process requirements)
  • Design/Build Facilities and Equipment (In depth look into a GMP facility requirement)
  • Maintain Facilities and Equipment (The Maintenance, Calibration, Use and Cleaning of Facilities and Equipment
  • Competency (The Training Requirements)
  • Sanitation and Good Housekeeping Practices (General requirements for all facilities)
  • Control for Quality (from Materials Receipt, Production, Packaging and Distribution)
  • Audit for Compliance (Basic Audit Concepts)
  • Prepare for BATTLE! - The Traceability Audit!

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 - Everything you wanted to know about CAPA,
• Non-Conformance - From Materials Supply, to Production to End of Use Complaints,
• Change Control - Documentation, Engineering, Production and Distribution,
• Deviations - Proper deviation management is essential for every company,
• Out of Specifications / Out of Trend - Correct Management of OOS and OOT for regulated industry,
• Complaints - Receipt, Qualifications, Risk Assessments and Remediation/Resolution,
• Recalls - The process, and rationale for success, and indications of failures,
• Product Traceability - The most under-rated requirement in the industry today,
• Audit - Internal, Agency, Customers and External Audit - Receiving, Conducting, and Self Assessments,
• Vendors, Suppliers, Contractors and Consultants - The Qualification Process explained. The Quality Agreements,

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
  

Questions and Answers