UDI: New Year, New Expectations

This webinar will cover how your company can positon itself to be ready for the broad array of UDI related activities for 2017 and 2018, including class I compliance, the Direct Marking requirement, the non-sterile implant mandate (“point of use”), new EU and UK requirements, as well as FDA’s intent to begin enforcing the UDI rules with inspections.

The discussion will include:

  • UDI for Class I devices
  • The (additional) Direct Mark requirement for class II devices
  • The need to have the UDI of an implant device available at the point of implementation
  • The EU UDI and UK-related requirements
  • Auditing your UDI program
  • Live Q & A session

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.

 

 

 

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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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