Preparing for FDA's Unique Device Identification Rule

This 90-minute webinar will review FDA's draft regulations for UDI and describe the new requirements for labeling medical devices. It covers the new regulations in 21 CFR Part 830, the changes to Part 820, the Quality System Regulation; Part 801, Labeling; Part 803, Medical Device Reporting; Part 806 Corrections and Removals; and other regulations.

Why Should You Attend:

In July 2012, the FDA issued the draft regulations for Unique Device Identification (UDI). This draft regulation describes new requirements of labeling medical devices as well as providing information to a new database that FDA maintains.

This webinar explores the explicit requirements as well as the hidden requirements in the draft UDI regulation.

Who Will Benefit:

This webinar is for people involved in understanding, analyzing, and implementing the UDI regulations.

People in the following roles can especially benefit from the knowledge in this webinar:

Quality Managers

Quality Professionals

Production Managers

Production Supervisors

Manufacturing Engineers

Production Engineers

Instructor Profile:

Dan, is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.

Note:

Use coupon code NB5SQH8N and get 10% off on registration, Valid till Dec 31st 2016.

For Registration:

http://www.complianceonline.com/preparing-for-fda-unique-device-identification-rule-webinar-training-702594-prdw?channel=sciencedz