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Home » Certificate Courses » Classroom Education » GS1 Healthcare US » U.S. FDA for UDI » 8/16/18: GS1 Standards for the U.S. FDA UDI Certificate Course- IL

8/16/18: GS1 Standards for the U.S. FDA UDI Certificate Course- IL

  • Date:Thursday, August 16, 2018, from 8:30 AM - 4:30 PM (CT)
  • Location:GS1 US Offices, 300 South Riverside Plaza, Suite 1400, Chicago, IL 60606

This one-day certificate training is designed for medical device labelers (e.g., manufacturers, repackagers, reprocessors, etc.) or any person involved in implementing U.S. FDA Unique Device Identification (UDI) using GS1 Standards. 

The U.S. FDA UDI Rule establishes a unique device identification system for medical devices. Under the rule, medical devices will be marked with a Unique Device Identifier (UDI) that will appear on the label and package of a device.  UDIs will be presented on device labels in both a human-readable format and a machine-readable format (e.g., a barcode).  Re-usable devices that need to be "reprocessed" before reuse will also be directly marked with a UDI.  In addition, device labelers will submit device information to a U.S. FDA database called the Global Unique Device Identification Database (GUDID).*

GS1 is an U.S. FDA-accredited Issuing Agency for UDI, and GS1 Standards can be used to implement the U.S. FDA UDI Rule. Whether you are continuing your Class III or Class II implementation or preparing for Class I, the GS1 Standards for U.S. FDA UDI Certificate Course provides the most comprehensive training we offer to help you with using GS1 Standards for your UDI implementation.

Attend this certificate course to gain valuable knowledge about how to use GS1 Standards for U.S. FDA UDI requirements that you can bring back to your company and enhance your own professional development.

 What You’ll Learn:

  • U.S. FDA Unique Device Identification overview.
  • What GS1 Standards can be used to implement U.S. FDA UDI requirements?
  • How to create properly formatted GS1 Global Trade Item Numbers (GTINs) for use as Device Identifiers (DIs).
  • How to use GS1 Application Identifiers for Production Identifiers (PIs)?
  • Which GS1 barcodes can be used for UDI?
  • What are the GS1 Standards for symbol encoding order and placement?
  • How to use the GS1 Global Data Synchronization Network™ (GDSN®) to submit data to the U.S. FDA Global Unique Device Identification Database (GUDID).

Who Should Attend:

This certificate training is designed for medical device labelers (e.g., manufacturers, repackagers, reprocessors, etc.) or any person involved in implementing U.S. FDA UDI using GS1 Standards. 

Need more info?

Not sure if this certificate course is for you? 
Attend our free 20-minute preview webinar (Note: you will need to create a free account to view) for a preview of the full-day  

Earn a Badge - your GS1 Standards credential:
Did you know when you successfully complete a GS1 US certificate course, you can earn an important credential in the use of GS1 Standards? And you can add this new skill to your online resume with a GS1 US Badge and share it via social media. Learn more about our badging program.

* Source: U.S. FDA Unique Device Identification System

Disclaimer: GS1 US is the local GS1 Member Organization that supports implementation of the GS1 System in the United States. GS1 US employees are not representatives or agents of the U.S. FDA, and the content herein has not been reviewed, approved or authorized by the U.S. FDA

GS1 US Offices,
300 South Riverside Plaza,
Suite 1400,
Chicago, IL, 60606

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$695.00