GS1 Standards for U.S. FDA UDI Online Certificate Course
AVOID COMMON MISTAKES AND RECEIVE GUIDANCE
Gain a deep understanding of GS1 identification, barcode, and data standards that can be used to implement U.S. FDA UDI Rule requirements.
PREPARE FOR UDI IMPLEMENTATION
This certificate course 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.
This on-demand course will help you gain valuable knowledge on:
- The U.S. FDA UDI Rule.
- The GS1 Standards that can be used to implement U.S. FDA UDI requirements.
- How to use GS1 Application Identifiers for your Production Identifiers (PIs).
- How to create properly formatted GS1 Global Trade Item Numbers (GTINs) for use as Device Identifiers (DIs).
- How to use the GS1 Global Data Synchronization Network™ (GDSN®) to submit data to the U.S. FDA Global Unique Device Identification Database (GUDID).
Learn how to Implement GS1 Standards for the U.S. FDA UDI Rule
1. Get an overview of the GS1 System, the U.S. FDA UDI Rule, and the GS1 Global Trade Item Number® (GTIN®)—including how to create a GTIN.
2. Gain an understanding of common UDI implementation mistakes and learn how to avoid them.
3. Learn GTIN assignment, packaging hierarchies and allocation, AIDC formats, and the basics of barcoding.
4. Get FAQ answers for implementation readiness.
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
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.