Effective Design Controls in Accordance with Subpart C of 21 CFR, Part 820 2016 covers topics such as:
- Clearly defining design inputs and outputs
- Effective Design and development planning
- Design verification versus design validation
- The design review process
- Design changes pre & post-design transfer
- When does the design transfer
- The Device Master Record (DMR)
- Maintenance of the Design History File (DHF)
Effective Design Controls in Accordance with Subpart C of 21 CFR, Part 820 2016 brings together senior attendees involved or interested in:
- Regulatory Professionals
- Quality Professionals
- Manufacturing Engineers
- Design Engineers
- Project Managers
