The Big Picture: UDI and the Product Visibility and Control Imperative

Upcoming Live Workshop on Thursday, February 22 at 11am PT / 2pm ET

As more countries, regulators, and payors introduce UDI and UDI-like requirements, the common overarching goal is to bring visibility, control, and connectivity to the many related regulatory and commercial device-related activities. These activities cover the total lifecycle of a device – including design, manufacturing, distribution, and postmarket surveillance – and will ultimately include long-term safety, effectiveness, and value. All of this necessitates a level of control and visibility over your products and processes that may not exist today, and which may require new systems to support these activities.

The discussion will include:

  • An overview of the direction of these global initiatives
  • The need for visibility and control of your devices and product data
  • Advice on the related systems and processes
  • Live Q & A session

About the Presenters:

Jay Crowley 6Jay 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 4Grant 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.

 

 

 

 

 

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  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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