A Six Sigma Approach to Product and Process Validation for World Class Productivity and Quality—4 days


Objectives: Provide an overview of the FDA view and requirements of Process Validation for the manufacture of medical devices and pharmaceuticals. Introduce a Six Sigma approach to validation as a strategy for achieving world class manufacturing status

  • Process Validation—an overview of the FDA view and requirements
  • Federal regulations, guidelines, and examples
  • How to start the process to conduct a validation
  • Why Validate
  • What Processes should be validated
  • Types of Process Validations
  • Documentation with examples
  • Revalidation
  • How to Get Started
  • Why a Six Sigma approach to process and product validation
  • Six building blocks for success
  • Basic Statistical Literacy—the language of Six Sigma
  • Measurement process validation
  • Validating manufacturing processes—control, capability
  • Introduction to designed experiments (DOE) and its role in process and product validation
  • DOE design and analysis workshop with simulated processes
  • The complete cycle
  • SOP development workshop