Verification and validation (V&V) go together and are vital for gaining and maintaining medical device market access and in the regulatory decision-making process. The intent of V&V is to establish that the device is designed and manufactured properly for its safety and effectiveness. Validation errors are among the most cited issues on FDA 483s.
Join us for this interactive workshop that will include presentations that explore V&V from various perspectives. Presentations will cover fundamentals, best practices and lessons learned on:
- Risk-based approaches to V&V in Medical device design, manufacturing and development
- Process validation – A guide to successful implementation
- V&V of in vitro diagnostic medical devices
- Regulatory decision-making processes for post-market design and process changes
The final program agenda and speaker list will be available soon.
Join your quality and regulatory colleagues from ASQ Biomedical Division Northern California Discussion Group (NCDG) and the RAPS San Francisco Bay Area chapter for an informative and interactive session on the impact V&V has on the medical device product lifecycle. Participation in this meeting is equivalent to 0.7 ASQ RU credits or six RAC recertification credits.
ASQ* and RAPS Members: $175
*Discount code provided to ASQ members