IT VALIDATION COURSE

The course catalogue in QV-Compliance A/S has been expanded with a course in IT Validation.

The 2 Day Course is based on GAMP® 5, 21 CFR Part11 and EU GMP Annex 11.

The Course Participants will be equipped with skills and knowledge to perform a full IT Validation of a Computerized Systems.

For Validation Strategy the V model is used.

Based on a predetermined Case Study, the course participants will attend 6 workshops

Learning objectives

  • Understanding GAMP® 5 & 21 CFR Part11 /Annex 11
    • Categorize SW & HW according to GAMP® 5
  • Performing Science Based Risk Assessment
  • Performing Supplier Assessment
  • Producing Validation Master Plan & Validation Plan
    • Validation approach according to GAMP® 5 categorization
  • Producing Specifications
    • User Specification Requirement
    • Functional Specification
    • Design Specification
  • Reviewing the Design & Software
  • Ensure Traceability
  • Producing System Description & Dataflow
  • Producing Testing documentation
  • Securing Maintenance throughout the Life Cycle
  • Understanding Incident, Change & Configuration Management
  • Producing Continuity Plan & Disaster Recovery Plan
  • Planning System Retirement

Course format

The Course is a combination of lecture-style leaning and active Workshops with participants working in small groups on assigned tasks.

Program

Day 1

  • Learning about GAMP®5 and 21 CFR Part11
    • Categorize SW & HW according to GAMP
  • Science Based Risk Assessment
  • Validation Master Plan / Validation Plan
    • Validation approach according to GAMP categorization
  • Workshop 1 & 2 & 3

Day 2

  • Requirements
  • Testing Computerized System
  • Maintenance
  • Incident, Change and Configuration Management
  • Continuity Plan / Disaster Recovery
  • Retirement of a Computerized System
  • Workshop 4 & 5 & 6

Course Material

Participants will receive the presentation, a complete guide, and other useful information.