2 Months Until Class II UDI Deadline – What You Need to Do Now to Comply

Are your Class II devices UDI compliant?  If not, join UDI experts Jay Crowley and Gary Saner for a look at what to expect and what to do in these final weeks before the Class II UDI deadline so you are compliant.

The discussion will include:

  • How to meet the Class II deadline of Sept. 24
  • Strategies for addressing non-compliant product
  • Most important lessons learned for Class II labelers
  • Recommendations for ongoing UDI compliance

Who should attend?

  • UDI Team Leaders/Members
  • Regulatory Leaders/Teams
  • Manufacturing, Operations and Supply Chain Logistics
  • UDI IT Support
  • Distributors with UDI Submission Responsibilities

 

About the Presenters:

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.

 

 

 

Gary Saner Reed Tech 1Gary Saner, Sr. Manager of Information Solutions in the Reed Tech Life Sciences group, is a subject matter expert on UDI and other structured content submissions to regulatory agencies. He has over a decade of experience in the Life Sciences industry and has worked for over 30 years in the areas of software development, process management and data conversion.

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Testimonials

  • 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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