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Home » Certificate Courses » GS1 Standards for U.S. FDA UDI Online Certificate Course

GS1 Standards for U.S. FDA UDI Online Certificate Course

  • Date:Online Course
  • Location:GS1 US Learning Management System (LMS)

Are you a medical device labeler involved in implementing U.S. FDA Unique Device Identification requirements using GS1 Standards? Learn about GS1 identification, barcode, and data standards that can be used to implement U.S. FDA UDI Rule requirements.

This four part web-series introduces you to the GS1 System and focuses on the GS1 Standards used within the context of the U.S. FDA Unique Device Identification (UDI) requirements, provides an overview the U.S. FDA UDI Rule and U.S. FDA Global UDI Database (U.S. FDA GUDID), reviews common mistakes often made during implementation and how to avoid them, and ends with recommendations on how to develop a successful UDI implementation plan.*

Since the recording of this course, the U.S. FDA has announced new information in the form of Draft Guidance, Final Guidance, extensions or modifications to aspects associated with some UDI requirements. Please refer to the U.S. FDA UDI website for more information on these updates. 

Need more info?

Please note: After purchasing the webinar, you will receive an email within four hours detailing instructions on how to access the course content.  Orders are processed hourly between 8am – 6pm ET. Once processed, you will receive a system generated email and the purchased course(s) will be assigned to your learning plan (usually within an hour). If you purchase outside these hours, the course(s) will be processed at 9pm, midnight or at 5am ET respectively. If you do not see your purchased course(s) in your learning plan within 24 hours of purchase, please contact training@gs1us.org

You will have unlimited access to the course for one year from the time of purchase. 

*For information about the rule, see the 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 is a U.S. FDA-Accredited Issuing Agency for UDI, and GS1 Standards are authorized for use in implementing the requirements of the U.S. FDA UDI Rule.

Time duration:
Approximate time to complete the series is four hours. An assessment is administered during the online training to test knowledge of the key takeaways. 

Who Would Benefit?
Medical device manufacturers or any person responsible for, or involved in, U.S. FDA UDI Compliance and the implementation of UDI requirements for their products.  

This certificate training consists of the following four courses:

Part 1: GS1 System Overview, U.S. FDA Unique Device Identification (UDI) Overview, Global Trade Item Number® (GTIN®) Overview and creation
Part 2: Global Trade Item Number (GTIN) assignment, packaging hierarchies and allocation; AIDC formats and basics of barcoding
Part 3: GS1 Global Data Synchronization Network™ (GDSN®) and U.S. FDA Global UDI Database (FDA GUDID)
Part 4: Common Unique Device Identification (UDI) implementation mistakes and FAQs; implementation readiness

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 profile with a GS1 US Badge and share it via social media. Certificate badge for this course is valid for three years from the time of issuance. Learn more about our badging program.

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$495.00
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$495.00