Curriculum
- 8 Sections
- 28 Lessons
- 1 Day
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- Introduction to Process Validation4
- 1.1What is Process Validation? Why is it Critical for Medical Devices?
- 1.2Key Terminologies: IQ, OQ, PQ, Verification, Validation
- 1.3Regulatory Framework: FDA 21 CFR Part 820 (Quality System Regulation); ISO 13485 Requirements; EU MDR and MDSAP Considerations
- 1.4Key Principles: Product Safety, Consistency, and Compliance
- Process Validation Lifecycle2
- Planning for Process Validation4
- Installation Qualification (IQ)4
- Operational Qualification (OQ)3
- Performance Qualification (PQ)3
- Continued Process Verification (CPV)3
- Documentation and Compliance5
- 8.1Creating Comprehensive Validation Reports
- 8.2Linking Validation to Quality Management Systems (QMS)
- 8.3Audit-Readiness and Common Non-Compliance Issues
- 8.4Case Studies: Process Validation Scenarios in Medical Devices: Equipment Validation; Sterilization Process Validation; Cleanroom Environment Validation
- 8.5Hands-On Activity: Developing and Reviewing an OQ/PQ Protocol; Statistical Evaluation of Validation Data
Case Studies: Process Validation Scenarios in Medical Devices: Equipment Validation; Sterilization Process Validation; Cleanroom Environment Validation
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