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

Website http://bit.ly/1pMMqjq | Edit Freely

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

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 managers

Quality managers and staff

R & D managers and staff

Regulatory and compliance managers and staff

Anyone with risk management responsibilities