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The healthcare industry is working to improve patient safety and fight skyrocketing costs in an era of significant change—including major legislation aimed at illuminating medical device and pharmaceutical supply chains from manufacturer to patient. Both pieces of legislation feature multi-phased implementations, and widespread adoption and compliance are proving challenging.

  • The FDA UDI rule on the establishment of a Unique Device Identification (UDI) system for medical devices provides a standardized way to identify devices across all information sources and systems, including electronic health records and device registries. Whether you are continuing to implement your Class II products or preparing for Class I, the GS1 Standards: UDI Certificate Course provides the most comprehensive training we offer to help you with your UDI implementation:
    • Understand practices for label quality and format through hands-on exercises
    • Learn how to correctly apply GS1 Standards for Device Identifiers and GUDID attributes
    • Gain a deep understanding of the UDI Rule and what it means
  • The Drug Supply Chain Security Act (DSCSA) addresses the exchange of information about an individual drug package’s travels through the supply chain. Serialization of packaging and the resulting traceability will enhance detection and notification of illegitimate products while facilitating more efficient recalls. Attend the GS1 Standards: DSCSA Certificate Course to learn:
    • GS1 Standards basics
    • Prepare for DSCSA requirements
    • Effectively implement lot-level management
    • Understand serialization and item-level traceability
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