Efficient Process Validation Strategies and Validation Master Plan (VMPs) for Medical Devices 2017 is a workshop that covers topics such as:
- Regulatory requirements, industry practice, and associated guidance documents relevant to process validation
- When and why validation is required
- The components of a good validation strategy
- The consequences of not validating or doing it poorly
- Successful validation master plans
- Application of problem solving methods to help asses which strategy is best in various situations
- Write a comprehensive protocol
- Requirements for validation documentation
- IQ/OQ/PQ validation sequence
- Common statistics for sound results
- When revalidation is needed
- Ongoing process monitoring and control requirements
Efficient Process Validation Strategies and Validation Master Plan (VMPs) for Medical Devices 2017 brings together:
- Compliance professionals
- Quality professionals
- Auditors
- Production supervisors
- Design/development engineers
- Manufacturing engineers
- Quality engineers
- Process owners