Statistical Concepts of Process Validation 2017 is a webinar that covers topics such as:
- 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
Statistical Concepts of Process Validation 2017 brings together:
- Quality Engineers
- Quality Managers
- Production Supervisors
- Production Managers
- Production Engineers
- Manufacturing Engineers
- Process Owners
- Design Engineers