LSPedia was thrilled to host members of the esteemed global standards organization, GS1 US, at our Farmington Hills, Mich. headquarters for a comprehensive training session on the latest developments around DSCSA. This event featured key experts: Andrew Meyer, Director of Global Standards; Ned Mears, Senior Director of Global Standards; Ullrich Mayeski, Community Engagement Director for Healthcare; and Teresa Williams, Director of Strategic Partnerships.
The session began with introductions and a detailed overview of GS1 and GS1 US, followed by insights from the recent PDG/FDA meeting. The discussion then shifted to the FDA, DSCSA, and GS1's pivotal role in these areas, covering:
- Who the FDA is and the fundamentals of the DSCSA
- Why GS1 is integral to these processes
- The specific role of GS1 US
The agenda was packed with valuable information on various critical topics:
- The Product Lifecycle and EPCIS: Detailed explanations of the Electronic Product Code Information Services (EPCIS) and its relevance to DSCSA were provided.
- EPCIS for DSCSA: Topics included Transaction Information (TI) and Transaction Statement (TS), implementation guidelines from version 1.2 to 1.3, necessary events for DSCSA, and non-DSCSA transactions supporting DSCSA.
- Transitioning Guidelines: Guidance on moving from GS1 US’ 1.2 to 1.3 guidelines.
- EPCIS for Chain of Custody: We explored the chain of custody, available resources, and practical examples.
- Single Issuance GLNs: Discussions covered the general concept of Global Location Numbers (GLNs), specific single issuance GLNs (1100, 1200), their capabilities, and resource navigation.
- A Look at FSMA: A high-level overview of the Food Safety Modernization Act (FSMA) highlighted its differences from DSCSA.
The training session was highly interactive, with multiple Q&A segments allowing participants to clarify understanding of complex issues and gain deeper insights. The closing segment provided an overview of solution provider resources, ensuring that attendees left the program equipped with actionable knowledge and tools.
The expertise and knowledge shared by the GS1 US team were invaluable. Their insights will enhance the LSPedia team’s efforts to ensure compliance and efficiency within the pharmaceutical supply chain. We extend our heartfelt thanks to Andrew Meyer, Ned Mears, Ullrich Mayeski, and Teresa Williams for their time and expertise.
Stay tuned for more updates as we continue to collaborate with industry leaders to bring you the latest in compliance and best practices.
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