Quality Training

Process Validation & Equipment Qualification Training

Objectives

Understand the key concepts of process validation and the associated benefits

• Appreciate how process validation links with the product development process
• Understand how ISO 13485, regulations and guidance (such as the IMDRF) applies to manufacturers of medical devices
• Correctly Identify when a manufacturing process requires validation
• Describe the elements involved in performing process validation from planning to execution
• Explain how to apply a risk-based approach to process validation
• Illustrate the importance of a validation master plan (VMP) and validation protocols
• Apply concepts learnt to develop a comprehensive VMP
• Understand the difference and purpose of installation (IQ), operational (OQ) and performance qualification (PQ)
• Apply concepts learnt to develop IQ, OQ and PQ protocols
• Define and create relevant acceptance criteria
• Understand and apply common statistical techniques used in process validation
• Outline how to maintain a state of validation through the lifecycle (Including revalidation)

  Content includes

  Day 1:
• Welcome & introductions
• Aims, objectives & structure
• What is process validation?
• What regulations, standards and guidance applies to process validation?
• Which processes require validation
• The process validation process
• Q&A

Day 2:

• Day 1 review
• How process validation links with product development
• Building a team
• Risk based approach to process validation
• Mapping the process to be validated
• How to develop a Validation Master Plan (VMP)
• Q&A
  

Day 3:

• Day 2 review
• Equipment Qualification (IQ, OQ, PQ)
• Establishing protocols and the different types of protocol
• Understanding acceptance criteria
• Statistical techniques and tools
• Q&A
  

Day 4:

• Day 3 review
• Protocol execution
• How to handle discrepancies and deviations
• Validation reports
• Validation life cycle, VMP and revalidation
• Q&A

Who should attend

This training course has great value for anyone who needs an understanding of or is engaged invalidation activities. Audience learning level: Basic to intermediate

Upcoming dates: