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Process Validation for Medical DevicesProcess Validation for Medical Devices
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Issues to be covered
- Process Validation for Medical Devices
- Regulatory Requirements
- Definitions
- When is validation required?
- Process Development and Optimization
- Statistical Aspects of Process Validation
- Risk Management – PFMEA
- Test Method Validation – TMV
- Process Validation Master Plan – PVMP
- Installation Qualification – IQ
- Operational Qualification – OQ
- Performance Qualification – PQ
- Process Validation Protocols & Reports
- Maintaining State of Validation and Re-Validation
- Retrospective Validation
- Process Validation Example
About The Lecturer
