Design Control: Documentation, Implementation, and Improvement
This course has been designed to learn design control, design verification, design validation, Design History File (DHF), use concepts and implement, learn about planning (inputs/outputs), and risk analysis to ensure your organization\'s devices meet intended uses / user needs and specified requirements. Learn about control of design changes and their results as well as transfer (design to product manufacturing).
Course Benefits
Participants will understand FDA, design control, the life cycle of the product, the Design History File (DHF) and Device Master Record (DMR).
Who Should Attend?
The target audience for this course consists of managers and professionals work in quality (QA/QC), compliance / regulatory affairs, manufacturing (operations), or engineering (design).
Topics Covered:
- Control of design in the Medical Device Industry
- Design control process elements
- ISO 9001vsISO 13485
- The Design Control Team
- Techniques for Design Verification & Validation
- QSR
- FDA Warning Letters related to design control
- The content of design history file (DHF) & Device Master Record (DMR)
- Process Model – approach to design control
- Project Management: product life cycle in relation to design control
- Exercises
Prerequisites:
Medical Device background, those in quality / regulatory affairs responsible for design control.
Please Note: Price includes materials, and certificate of attendance.