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Event NameCompliance Global 2017 Update on Global UDI Initiatives for Medical Devices
Event Date(s) Wednesday, June 21, 2017  to Wednesday, June 21, 2017
Event Location Online
New York, New York

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, the NHS e-procurement and PEPPOL programs in the UK, and the development of initiatives in other countries including Australia, Canada, Japan and Asia.

Unique identification and barcoding 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.

What has taken this major industry so long to adopt UDI and barcoding? Why are both manufacturers and hospital systems reticent about implementing it?

Why Should You Attend

Knowledge, planning, preparation. These 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.

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 in this Webinar

  • 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

Learning Objectives

  • 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

Who Will Benefit

  • Regulatory Affairs Professionals
  • Quality Assurance Professionals
  • Labeling Specialists
  • Master Data Managers
  • Supply Chain Professionals

Speaker Profile

Lena Cordie has over 20 years of quality and project management experience including 10 years in project management at Target Financial Services and 11 years as Director of Operations at Key Surgical, a medical device company focused on sterile processing, personal protection, and OR products. In this position she was responsible for overseeing all quality and regulatory functions, production, product procurement, and order fulfillment.

As a consultant at Qualitas Professional Services, LLC, Ms. Cordie now focuses on helping companies implement quality management systems, UDI solutions for labelling and FDA GUDID submissions, and providing validation, documentation and project management resources to global medical device companies.

She is an active member of AAMI (Association for the Advancement of Medical Instrumentation) – serves as a voting member of many sterilization standards committees and co-chairs the terminology committee, ISO (International Organization for Standardization) – serves as a US representative and participates in ISO/TC 198 (ISO 17664 & ISO 11139) and ISO/TC 210 (ISO 13485 & ISO 15223) working groups and RAPS (Regulatory Affairs Professionals Society) – serving as chairperson of the RAPS Twin Cities Chapter.

SponsorRebound Therapeutics
Host CompanyRebound Therapeutics
Contact Information Phone: +1-844-746-4244
Fax:   +1-516-900-5510  
More Information