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FDA: UDI and GUDID Compliance

26468 E Walker Dr, Aurora, Colorado 80016-6104
26468 E Walker Dr, Aurora, Colorado 80016-6104 Aurora, CO 80016  
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Start:   Thursday, May 31, 2018  1:00 PM
End:   Thursday, May 31, 2018  2:00 PM

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Event Features: Business-Related

Neighborhood: Avenue of the Arts


       



https://bit.ly/2I05GF5


OVERVIEW The UDI system has the potential to improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more quickly, better target recalls, and improve patient safety. The FDA has worked closely with industry, the clinical community and patient and consumer groups in the development of this rule. Understand the significance of UDI, GS1 standards, and the GTIN (Global Trade Item Number) which are already recognized across the healthcare industry as a unique identifier of medical devices, surgical products and healthcare supplies.
WHY SHOULD YOU ATTEND
This webinar will provide valuable and additional insight and an overview for the medical device and IVD companies involved in establishing and maintaining a state of compliance and meeting compliance deadlines for UDI.
AREAS COVERED
• Introduction to UDI and History
• Final Rule: UDI regulation
• UDI is a unique numeric or alphanumeric code that consists of two parts: DI and PI
• How GS1 Standards can be used to meet UDI requirements
• Tools and resources, including guidance, available to help you get started
• Gain an understanding of UDI in practical terms

LEARNING OBJECTIVES
This webinar provides an understanding of UDI in practical terms and also explains what the compliance expectations for UDI are.
WHO WILL BENEFIT
Employees and personnel who will benefit include:
• All levels of management and departmental representatives any anyone who desire a better understanding or a 'refresh' overview of FDA’s Unique Device Identification Final Rule
• CRO’s
• Regulatory Affairs/RA Specialists
• Clinical Affairs
• Project Leaders for UDI Compliance
• Quality Control/Quality Assurance
• Compliance
• Marketing & Sales
• Distributors/Authorized Representatives
• Engineering/Technical Services

For more detail please click on this below link:
https://bit.ly/2JHvC9z

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