Global UDI Database - Account Setup & Security (Webinar)

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

Overview |  Agenda |  Speakers |  Logistics |  Fees

Overview

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

Agenda

Click here to Download.

Speakers

Indira R. Konduri, GUDID Program Manager, FDACDRHOSBInformatics Staff

Jeffrey Secunda, Vice President, Technology & Regulatory Affairs, AdvaMed

 

Hotel & Meeting Logistics

Registration Fees

AdvaMed Member Registration: $195.00
Accel Member Registration: $95.00
Government and Non-Profit Registration: $95.00
Non-Member Registration: $295.00


Please contact skinchen@advamed.org for Group Discounts (Discount does not apply to AdvaMed Accel, Government, or Non-Profit Organizations)