The objective of this course is to provide students with key concepts and fundamentals associated with the process validation cycle such as VMP, IQ, OQ and PQ, and the correlation with the regulations and standards.

Throughout the course, students will engage in hands-on learning experiences, applying their knowledge of Process Validation scenarios. 

At The End Of The Course You Will Be Able To

• Understand the purpose of Process Validation (PV) in the medical device industry.
• Learn about the difference between the concepts of verification and validation as per ISO 13485 and 21 CFR Part 820 requirements.

• Learn about key process validation elements and their purpose for:
  • Validation Master Plan (VMP)
  • Equipment Qualification (EQ)
  • Test Method Validation (TMV)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)

• Understand the importance of other elements associated to process readiness such as:
  • Manufacturing Readiness
  • Risk Management
  • Material Readiness
  • System Setup
  • Facilities Setup

• Learn about the Process Validation Lifecycle – State of the Art.

• Apply the class learning to solve real life cases associated to process validation.

Course Content

1. Purpose of Process Validation.
2. Process Validation from the Regulation Perspective.
3. Elements of Process Validation (EQ, OQ, TMV, PQ).
4. What is the starting point (MVP).
5. Other Elements to Get Started
6. Process Validation Lifecycle – Maintaining the state of the art.