This Process Validation training course is a 2 Day public programme, designed to provide attendees with the knowledge and skills needed to comply with the process validation requirements of the FDA’s Quality System Regulation and information on how to implement an effective validation programme. The course includes process validation examples from pharmaceutical and medical device manufacturing processes.
Process Validation is a term used in the medical device industry to indicate that a process has been subject to such scrutiny that the result of the process (a product, a service or other outcome) can be practically guaranteed. This is vitally important if the predetermined requirements of product can only be assured by destructive testing.
Using a series of formal presentations, combined with various practical exercises and case studies, the workshop is designed to be interactive, and so promote understanding of validation, with focus on Process Validation.
- Module 1 Introduction to Validation
- Module 2 V-model approach to validation
- Validation life cycle approach
- Validation planning
- User Requirement Specification
- Specifications & Testing
- Module 3 ISO 14971 & Risk Assessment
- Module 4 Installation & Operation Qualification
- Module 5 Operational Qualification (Process)
- Module 6 Sampling Plans & Capability Analysis
- Module 7 Performance Qualification
- Module 8 Maintenance of validated systems
- FDA Warning Letters
This Process Validation training programme may be beneficial to all personnel directly involved in process validation, as well as, new or seasoned operational personnel who will eventually participate in such efforts. Individuals in management who interact with the above or interact with regulatory agency inspectors to rationalise or defend validation programs will also benefit from attending this course.
No experience of Process Validation is necessary though some knowledge of processes would be beneficial.
Classroom based, instructor lead, practical hands on course.