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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.

Your Quality Management System (QMS) should be able to address these questions quickly and easily. If not, then your team needs to attend this webinar!

Areas Covered in the Webinar:

An explanation of the draft regulation.
When a UDI is required
What is on a label
What is in the new FDA database
A description of the changes to the device regulations
New Part 830 on Unique Device Identification
Part 801 on Labeling
Part 803 on Medical Device Reports
Part 806 on Corrections and Removals
Part 807 on Registration and Listing
Part 820 on the Quality Management System
Part 821 on Device Tracking
An analysis of the “hidden” requirements
Will a new UDI require a design change
When will a new UDI trigger a new 510(k) and vice versa
When does an update to the DMR require a new UDI
Implementation Recommendations
Integrating requirements
Many small changes touch the whole system
What can we expect FDA Inspectors to look for
How could Inspectors compare UDI, device listing, MDRs, and recalls
Will FDA have the potential for data mining before the inspection

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
Design Engineers

Official Website:

Added by complianceonlinecom on November 7, 2012