This training program will offer attendees an understanding of the reasons for design control and highlight the key elements of a design control program. The FDA has concluded that a well-controlled design process with risk analysis, change control, design reviews and hardware/ software validation will greatly reduce the chances of an unsafe product. In accordance with the same, This webinar will also discuss how risk management fits into design control compliance.
Why Should You Attend:
This course will explain how to setup and manage a design program that will meet FDA requirements and minimize chances of your medical device being recalled. A design control program will also help ensure your projects are completed on time and within budget.
The other key learnings in the course include:
Areas Covered in the Webinar:
Who Will Benefit:
Edwin Waldbusser is a consultant retired from the industry after 20 years in management of development of medical devices (5 patents). He has been consulting on regulatory issues related to design control, risk analysis and software validation for the last 7 years. Mr. Waldbusser has a BS in mechanical engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness Network.
Note: Use coupon code 232082 and get 10% off on registration.