Design Controls & Risk Management
An Integrated Product Development Approach
The course is 2 days of intensive workshop instruction which provides an integrated analysis of design control & risk management regulation concepts (21 CFR 820.30/ISO 13485 / ISO 14971) in a product development context. The course agenda walks attendees through a typical product development lifecycle which is broken out into five development phases. Workshops, exercises and quizzes are introduced throughout the course to reinforce principles and to provide attendees with a practical and hands-on experience.
This workshop is appropriate for medical device professionals with minimal to moderate experience with design control regulation. This course uses a unique blend of instruction from industry experts and resources from FDA regulation and guidance.
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- Gain a solid understanding of design control and risk management regulation concepts
- Develop a skill set for implementing design controls and risk management best practices
- Learn how to integrate design control and risk management regulation into the project management process
- Learn how to integrate a phased development approach into the product development lifecycle
- Develop methods for integrating risk management across all design control elements
- Recognize the differences between 21 CFR 820.30 and ISO 13485 design controls
Included with the Course
- A free copy of: Design Controls, Risk Managment and Process Validation for Medical Device Professionals (2016 v.1) (440+ pages) ($170 value)
- Extensive course notes and power point presentation