UDI Adoption: Safer Patients, Smarter Supply ChainsWednesday, May 27 | 11am - 12:30pm EDT
Stop chasing deadlines and start leading with compliant, audit-ready data. Join us to master the latest UDI requirements, learn up-to-date, practical approaches to UDI submission and labeling to avoid bottlenecks, reduce errors, and ensure global market access. This seminar provides actionable pathways for GUDID/EUDAMED compliance, advanced data management strategies, and practical solutions to meet regulatory hurdles and enable supply chain efficiency.
|
|
|
AGENDA
State of the UDI Regulations Globally Jay Crowley, USDM Life Sciences As UDI requirements evolve from system rollout to active compliance oversight, 2026 marks a critical turning point for global medical device regulation. This session provides a comprehensive update on the state of UDI regulations worldwide, highlighting key 2026 milestones, including mandatory EUDAMED UDI/Device module use, new requirements in Australia, and expanding data obligations in China and Brazil. US UDI Regulation Successes and What’s on the Horizon Indira Konduri, US FDA As the UDI system marks over a decade of implementation, this briefing will discuss the impact of UDI on patient safety and postmarket surveillance, outline the final implementation phases, emerging compliance policies, and the future role of UDI in digital health initiatives. Attendees will gain direct insight into FDA's evolving expectations for UDI adoption in clinical workflows. Building a Clinically Integrated Supply Chain Using the UDI as the Source of Truth Dr. James Tcheng , Duke Medical Center Explore how Duke Medical Center transformed its supply chain by utilizing the UDI as the "source of truth" to improve safety, efficiency, and data accuracy. This session, featuring Dr. James Tcheng, outlines a people, process, and technology roadmap for implementing a UDI-based clinically integrated supply chain. Fundamentals of Becoming Compliant – Panel Discussion Dennis Black, BD; Debbie Greenway, FEIG Electronic; and Lana Makhanik, VueMed Ensure your medical devices meet FDA requirements by focusing on the core of compliance: label quality. This session covers fundamental UDI labeling, emphasizing accurate Human Readable Interpretation (HRI) and machine-readable AIDC data carriers. Learn best practices for verifying barcode quality, ensuring proper formatting, and mapping data to GUDID to avoid common compliance pitfalls. UDI and Data Standards: What’s Next and Why It Matters Beth Wells, GS1 US and Karen Fleshman, Synchcor This session explores the evolution of FDA UDI compliance from mandatory labeling to strategic data utilization. Industry experts will discuss GUDID reporting best practices, the impact of standardized data on supply chain efficiency, and how UDI integration improves patient safety, adverse event reporting, and recall management. Ask The Experts – all speakers |
|
