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Who:
Scott Brown, director of global standards, GS1 US; Beth Gibson, senior director industry development, medical devices, GS1 US; and John Roberts, industry development director, GS1 US
What:
These one-day advanced workshops will focus on the use and implementation of GS1 Standards, including Global Trade Item Number® (GTIN®), GS1 barcodes and the Global Data Synchronization Network™ (GDSN®), as a method to help meet the FDA UDI rule compliance requirements, and to load the Global Unique Device Identification Database (GUDID) with device information. Recommendations on how to develop a successful implementation project team will also be discussed.
When and Where:
February 18, 2016
8:30 a.m. - 4:30 p.m.
GS1 US Offices - Lawrenceville, NJ
April 28, 2016
8:30 PM - 4:30 PM
GS1 US Offices - Chicago, IL
June 30, 2016
8:30 PM - 4:30 PM
GS1 US Offices - Lawrenceville, NJ
August 11, 2016
8:30 PM - 4:30 PM
GS1 US Offices - Chicago, IL
Who Should Attend:
The workshop is designed for healthcare medical device manufacturers and individuals with front-line responsibility for implementing UDI within their organizations and for submitting device information to the GUDID.
Details:
GS1 is an FDA-accredited issuing agency for UDI. Global GS1 Standards, administered in the U.S. by GS1 US, are authorized for use by manufacturers to address requirements of the FDA UDI rule. The FDA established this system starting in 2013 to adequately identify medical devices through their distribution and use, leading to enhanced patient safety.