Process, Scope and Expected Benefits from Assessing your UDI Program

 

FDA’s interpretation and understanding around UDI implementation continues to evolve and UDI will become a central focus of FDA inspections. In addition, the accredited issuing agencies are continuing to update and improve their guidance and standards. Plus, more regulators/countries are beginning to develop their own UDI systems. It is critical that your solutions are robust, extensible, well documented and defendable. It is also critical that all of the conforming amendments to the UDI Final Rule are implemented correctly, your processes and systems are capable of transacting at a UDI level and all relevant staff are properly trained.

The discussion will include:

  • UDI implementation issues – US and Globally
  • Barcode verification
  • Incorporation of the conforming amendments
  • Updating and developing SOPs
  • Live Q & A session

About the Presenter:

Jay Crowley 6Jay Crowley is the Vice President of UDI Services and Solutions at USDM Life Sciences. Jay 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.

 

 

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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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