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
- 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
The Course is a combination of lecture-style leaning and active Workshops with participants working in small groups on assigned tasks.
- 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
- Testing Computerized System
- Incident, Change and Configuration Management
- Continuity Plan / Disaster Recovery
- Retirement of a Computerized System
- Workshop 4 & 5 & 6
Participants will receive the presentation, a complete guide, and other useful information.