SEMINAR ON APPLICATION OF ISO 1 THE NEW ISO TR 2015 - Medical Device Risk Management A to Z - Best Practices for Effectiveness and Efficiency: 2-day In-person Seminar
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Category FDA GXP Compliance - Medical Devices;
Deadline: January 29, 2015 | Date: January 29, 2015-January 30, 2015
Venue/Country: San Diego, United Arab Emirates
Updated: 2014-12-23 15:32:19 (GMT+9)
Call For Papers - CFP
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.Who will benefit:Project managersQuality managers and staffR & D managers and staffRegulatory and compliance managers and staffAnyone with risk management responsibilities
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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