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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)

UDI Online Badge

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.

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). Reusable 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).*

The GS1 Standards for U.S. FDA UDI Online Certificate Course was developed to help medical device labelers avoid common mistakes and receive guidance on how to use GS1 Standards for the U.S. FDA UDI Rule.

Attendees will gain a deep understanding of GS1 identification, barcode, and data standards that can be used to implement U.S. FDA UDI Rule requirements. Including, but not limited to:

  • The GS1 Standards that can be used to implement U.S. FDA UDI requirements
  • How to use GS1 Application Identifiers (AIs) for my Production Identifiers (PIs)
  • How to create properly formatted GS1 Global Trade Item Numbers (GTINs) for use as Device Identifiers (DIs)
  • Options for submitting data to the U.S. FDA GUDID

Need more info?

  • Download our course description flyer.
  • Want to register and need help to get budget approval from your management team? Use this justification letter template to help make your case.
  • Not sure if this certificate course is for you? Check out a free 10-min webcast preview (you will need to create a free account to view).
  • Have more questions and would like to speak to a training specialist? Please call 937-428-3796. Specialists are available Monday-Friday, 8am-5pm EST or Email us at training@gs1us.org

Please note: 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.

*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 will be administered throughout this course to gauge your understanding of the material. There is no additional charge for the assessment, which is for review purposes only.

Who would benefit?

This certificate course is designed for medical device labelers, such as:

  • Manufacturers
  • Repackagers
  • Reprocessors

Or any others involved in implementing or managing U.S. FDA Unique Device Identification (UDI) using GS1 Standards, like:

  • Master Data Managers
  • Package Design and Management
  • Operations and IT

This certificate training consists of the following training modules:

  • Module 1: Overview of GS1 Standards
  • Module 2: How to Use Your GS1 Company Prefix (EAN/UPC)
  • Module 3: How to Create and Manage Your Global Trade Item Numbers (GTINs)
  • Module 4: GTIN Management Standard
  • Module 5: How to Barcode Your Products
  • Module 6: GS1 Standards for U.S. FDA UDI Module is divided into the following 6 Lessons with a Resource Library at the end:
    • Lesson 1: U.S. FDA UDI Rule Overview and Definitions
    • Lesson 2-4: GS1 Identify, Capture, and Share Standards for the U.S. FDA UDI Rule
    • Lesson 5: Review of Exceptions, New U.S. FDA UDI Guidance, and FAQs
    • Lesson 6: Implementation Readiness and the “Project vs. Program” Approach

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. (Note: the GS1 US Badge is issued within three weeks of course completion).

GS1 US certificate course badges are valid for three years from the date of issue. For more info, visit our Badging Program page.

Register

$495.00
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