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