Risk Based Design Control – The new paradigm for Medical Device design
Date : 25 February 2019
Time : 02 : 00 PM EST
Duration : 60 Minutes
J. Lawrence Stevens, RAC, who has over 20 years of FDA experience encompassing virtually all of the FDA field positions. Also eighteen years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the medical device industry. He has personally designed quality systems, prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, was the Industry Representative on the FDA Circulatory Systems panel. Finally, a seasoned educator/speaker with over 250 public presentations to audiences ranging from senior executives, physicians, technical personnel, other medical personnel, major media, and the general public. As a consultant, he has presented over 20 webinars on FDA requirements.
Design Control is essentially a quality assurance program for the Research and Development department. The VP or Director of R&D owns the design control effort. Over the years many companies have included the design control requirements into their project plans and build the Design History File as part of the development process. Nothing has changed in these basics, but FDA’s and ISO’s expectations are now that risk management is built into the design and development process. Thus, the emergence of risk-based design control. This approach will be discussed in detail during this webinar.
- The 2019 approach to design control
- What do FDA and ISO say about it?
- How do you present it to management?
- What are the key steps in risk-based design control?
- How to implement risk-based design control in our company
Course Level - Intermediate
Who Should Attend
VP, Directors, Managers of R&D, Project Managers in R&D, VP, Directors, and Managers of QA, Internal Quality Auditors, QA Consultants to the medical device industry
Why Should Attend
We must be prepared for quality audits. The MDSAP, ISO 13485:2016 certification, FDA PAI, and routine QSIT inspections. If these acronyms are familiar to you, then this is a webinar you should attend.
FDA Design Control has been around since 1996 when FDA published the design control regulations as 21 CFR Part 820.30.
For many years establishing a design control SOP that included all the sections of Part 802.30 was all FDA expected. But things have changed, and FDA now expects a risk-based approach in addition to the basics.
- Speaker: J. LAWRENCE STEVENS
- Webinar Code: LAWR-0003