The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: March 20, 2014 at 8:30am to March 21, 2014 at 4:30pm
Location: Boston Marriott Copley Place
Street: 110 Huntington Ave
Website or Map: http://www.complianceonline.c…
Event Type: medical
Organized By: ComplianceOnline
Latest Activity: Mar 5, 2014
FDA views risk management as an essential process both during inspections and in the review of pre-market submissions. Effective risk management has become critical to medical device manufacturers and this interactive two day seminar is aimed at providing medical device professionals with the tools necessary for effective risk management implementation in device manufacturing and marketing.
It will address both the fundamentals of risk management as well as current best practices for ISO 14971 compliance. The course will look in detail at risk management requirements in the US, the EU, and other parts of the world. Taught using an interactive workshop format, attendees will practice all the risk management activities required by ISO 14971. Exercises are aimed at demonstrating efficient and effective use of risk management, including best practices in applying the ISO standard. Emphasis is placed on practical solutions to practical problems. Seminar instructor Harvey Rudolph, Ph.D., one of the authors of ISO 14971 and a 25 year veteran of FDA, will also provide insight on the guidance contained in new ISO TR 24971 (Guidance on the application of ISO 14971) and how to integrate risk management into your quality management system.