Training Course Syllabus:

Update on Global UDI Initiatives and Post-Submission Responsibilities Webinar

Unique identification and bar-coding are neither new technologies nor innovative concepts. But incorporation of UDI into the medical device industry has been long discussed and planned and slow to be implemented. Regardless of which category/class of Device you manufacture, you should also be working on your post-submission UDI maintenance plan. What has taken this major industry so long to adopt UDI and bar-coding? Why are both manufacturers and hospital systems reticent about implementing it?

Objectives of the Presentation

Be aware of what UDI information to look for and where to find it
Be able to outline a general UDI strategy by identifying and prioritizing the "critical to business" regulations you need to address first
Activities required post submission to maintain compliance
Monitoring UDI regulations and requirements changes

Why Should you Attend

Knowledge, planning and preparation are the foundation principles for any successful and sustainable project, especially one as global and multi-faceted as Unique Device Identification. It is never too soon to begin increasing your awareness of the various programs being established and your knowledge of the requirements and timelines to help you begin planning and preparing for what is inevitably going to be a challenging, resource-heavy, and time-consuming process.

Organizations implementing UDI need to address UDI compliance as more than just a project with a start and end date. Consider it for what it must be to be effective and successful - a process in its own right, incorporated throughout your established quality management system (QMS). Post-submission compliance activities are frequently overlooked in the frenzy of UDI implementation.

Medical device manufacturers of all sizes, locations, product class, and expertise are in the same precarious position of uncertainty and waiting. By strengthening your UDI intelligence now, you will be better positioned to lead your organization in this global initiative.

Areas Covered

Intent of Unique Device Identification regulations
Why are countries creating regulation for UDI?
What is the purpose of the regulation?
Current efforts & hurdles to harmonization
Key differences in proposed regulations
Standards
Label requirements
Data reporting
Comparison of IMDRF/ US FDA/ EU
Timelines - known & anticipated
Impact of UDI on global trade & commerce, product cost, and patient safety
Enforcement actions
Post Submission Responsibilities

Webinar Time

10:00 AM PDT, 01:00 PM EDT | Duration: 90 Minutes

Seminar Summary:

This webinar will provide updates on the progress of Unique Device Identification regulations around the world, including the status of the FDA's implementation, requirements for UDI in the new EU MDR, and the development of initiatives in other countries including Australia, Canada, Japan and Asia. (see full course description)

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