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Utilizing GS1 Standards to Comply with FDA UDI Requirements
Utilizing GS1 Standards to Comply with FDA UDI Requirements


 
Our Price: $395.00

Product Code: WB-7000
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About the Product
Includes 50 minute Windows Media Video File and PowerPoint presentations for immediate download.


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.
  • 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

Speaker:

Beth Pashko
RA/QA Lead
Covidien


Target Audience
  • Quality Assurance
  • Regulatory Affairs

Target Industry

  • Medical Device Manufacturers
  • Diagnostic Manufacturers

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