Program Overview
This comprehensive course on equips participants with the knowledge and skills to understand the stages, regulations, and practical implementation of process validation. Participants will learn about key regulatory requirements (FDA 21 CFR Part 820, ISO 13485), the stages of process validation, and effective strategies for planning, executing, and documenting validation processes. The course includes real-life case studies, hands-on protocol development, and interactive group activities to ensure participants can implement process validation strategies that mitigate risks and enhance product quality.
Features
- Understand the concept, lifecycle, and stages of process validation.
- Gain knowledge of global regulatory standards and compliance requirements.
- Develop the skills to effectively plan, execute, and document process validation.
- Apply hands-on activities and case studies to reinforce process validation concepts.
Target audiences
- Process Engineers
- Quality Assurance/Control Teams
- R&D Teams
- Validation Engineers
- Production/Manufacturing Leads
Curriculum
- 8 Sections
- 28 Lessons
- 1 Day
Expand all sectionsCollapse all sections
- 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
Instructor
