Statistical Concepts of Process Validation 2017

Key Topics

• Explain the FDA’s approach as documented in Warning Letters
• Understand the QSR requirements for process validation
• State the statistical model that links process input and process output
• Understand the ISO 13485 requirements for process validation
• Understand the role of process capability and describe the desired values of the indices
• Link sampling verification to the process model
• Describe the role of challenge points in Operational Qualification
• Understand the role of designed experiments in determining the input parameter space
• Recognize the role of process validation in Risk Management

Who should Attend

• Quality Engineers
• Quality Managers
• Production Supervisors
• Production Managers
• Production Engineers
• Manufacturing Engineers
• Process Owners
• Design Engineers