Global UDI Database - Account Setup & Security (Webinar)

December 10, 2013, Webinar from 1:00PM - 2:30PM EST

In this 90-minute webinar, AdvaMed will introduce participants to the basic elements of the UDI regulation including the UDI labeling, UDI database elements, and the timeline for compliance.

UDI Labeling:
Each Packaging level
Kits
UDI Direct Marking
Standalone Device Software

UDI Database:
FDA Global UDI Database (GUDID) Guidance
Data Elements
External & Internal Data
Electronic Data Submission

Then, take a comprehensive dive with FDA CDRH OSB informatics staff as they explain the structure of the Global UDI Database (GUDID) and the details of account set-up and maintenance:

GUDID Overview
Submission options
Account User Roles
Use of DUNS numbers
GUDID Coordinator
Labeler Data Entry (LDE) User
Third Party Submitters
Account Management and Status