Process Validation

• Module 1. Background and History
• Module 2. Current Legislative Requirements
• Module 3. Validation Management
• Module 4. Validation Description Type
• Module 5. Exercise
• Module 6. When to Qualify and Validate
• Module 7. Test Protocol
• Module 8. Exercise
• Module 9. Alignment of Operation, Validation and Calibration parameters
• Module 10:Measurement, Analysis, and Improvement
• Module 11:Key - Plant Senior Management "buy in"
• Module 12. Validation Test Report
• Module 13. Operational Qualification
• Module 14. Validation of Tooling
• Module 15. Process Validation
• Module 16. Exercise
• Module 17. Change Control
• Module 18. Software Validation

Programme Overview

This course  is designed to provide detailed understanding of the process of validation for regulated industries, with particular focus on validation for the manufacture of medical devices and the requirements of ISO EN 13485 and FDA QSR. The course aims to explore in some depth validation activities, the reasons of these activities and how best to meet these requirements.

Who is the course for

Validation Engineers

Quality Engineers

Personnel planning validation activities

This course is designed for Senior Management, Quality Managers, Quality Engineers, QA and Regulatory personnel working on QMS’s in industry.

Learning outcomes

Understand regulatory requirements around Validation

Understand in depth process validation activities, including cleaning and software

Understand structure of Protocols, Test Reports, Master Validation Plan, User Requirement Spec