USDM Life Sciences announces a live workshop with Jay Crowley and Grant Hodgkins.
“I’m excited to discuss the globalization of UDI,” said Jay Crowley, VP of UDI Services and Solutions at USDM life Sciences. “As UDI-like regulations continue to materialize around the world, we must pay particular attention to issues of control and visibility.”
As more countries, regulators, and payors introduce Unique Device Identification (UDI) and UDI-like requirements, the common overarching goal is to bring visibility, control, and connectivity to the many regulatory and commercial related activities of medical devices. These activities cover the total lifecycle of a device – including design, manufacturing, distribution, and post market surveillance – and will ultimately include long-term safety, effectiveness, and value. All of this necessitates a level of control and visibility over products and processes that may not exist today, and which may require new systems to support these activities.
The workshop will discuss:
- An overview of the direction of these global initiatives
- The need for visibility and control of your devices and product data
- Information on the related systems and processes
- Live Q&A
Jay Crowley is the Vice President of UDI Services and Solutions at USDM Life Sciences. He was Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. Jay developed the framework and authored key requirements for the FDA’s Unique Device Identification system.
Grant Hodgkins is Vice President of Supply Chain Services and Solutions at USDM Life Sciences. With over 30 years of experiences in the Life Sciences, Grant assists USDM Life Sciences clients with Pharmaceutical Track and Trace, Enterprise Resource Planning (ERP), Product Information Management (PIM), Product Lifecycle Management (PLM), Manufacturing Execution Systems (MES) and other commercial enterprise solutions.