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Subscribe NewsletterUse of Risk Management during Process and Design Validation
Product Id
:
600023
Overview: This presentation will discuss this critical interface between these three elements and give medical device manufacturers practical advice on implementation of a process that meets the requirements of all three areas.
In the area of product design, one of the most critical and least understood phases is Design Validation at the interface with Process Validation. The international standard on medical device Risk Management impacts this phase through a requirement for verification of risk control effectiveness. In order to accomplish Design Validation, Process Validation must be partially completed. In order to complete Design Validation, regulators expect Risk Management to be completed.
In the area of product design, one of the most critical and least understood phases is Design Validation at the interface with Process Validation. The international standard on medical device Risk Management impacts this phase through a requirement for verification of risk control effectiveness. In order to accomplish Design Validation, Process Validation must be partially completed. In order to complete Design Validation, regulators expect Risk Management to be completed.
Areas Covered in the Session:
- Regulators expectations for Design Validation
- Product requirements for Design Validation
- Providing validated production for Design Validation
- How does risk management guide Process Validation?
- What aspects of risk control must be included in Design Validation?
- Developing a validation plan and protocol that meets regulatory requirements
Who Will Benefit:
- Project Managers
- Design Engineers
- Quality Engineers
- Process Engineers
- Design Validation Team
- Process Validation Team