50 Minute Video | Beth Pashko, Covidien
 

In July of this year, the FDA released drafted regulations that will require the implementation of a national unique device identification (UDI) system, aiming to improve safety and efficiency in US healthcare systems. The concept of this system has the potential to be effective only if UDI is captured, stored, integrated and exchanged by all stakeholders in the US and abroad. GS1 healthcare, a diversified global healthcare group which aims to develop and implement global standards by bringing together experts in healthcare to enhance patient safety and supply chain efficiencies, has applauded the FDA's steps toward improving patient safety through UDI's. Implementing this system on a global scale is sure to be quite complex for both manufacturers and regulators and becoming a member of a Standards Development Organization such as SG1 can assist in overcoming challenges. This webinar discussed critical points within the UDI system and highlighted how the GS1 system of standards is meeting them.

Topics Covered

  • Status update and guidance on global UDI
  • Understanding the intricacies of the UDI system
    • Differentiating device indicator and product indicators
    • UDID
    • AIDC
  • Allocation of UDI codes
    • Defining what products require UDI
    • Coding for product accessories/product packs
  • Strategies and methods for internal preparation

Participants that will find this webinar most beneficial will be those involved in medical device and diagnostic companies.  Job titles of attendees that will be most applicable for this session will be:

  • Quality Assurance
  • Regulatory Affairs

 

Beth Pashko
RA/QA Lead
Covidien

Beth Pashko, RA/QA Lead, Covidien

Beth Pashko is the RA/QA Lead for the Covidien UDI project. She has held various Quality System and Regulatory positions at companies such as Covidien, Boston Scientific, Blackstone Medical (currently Orthofix) and Waters. In Beth's current role, she is responsible for successful execution of projects within the Global UDI Program, including participation in workgroups developing commentary response to the FDA draft ruling.

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