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Process Validation for Medical DevicesProcess Validation for Medical Devices
- 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 ...Continue reading
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