Update on Unique Device Identifier for Device Manufacturers
Overview:
Recent reports identified several potential benefits to widespread use of UDI, such as reducing medical errors, facilitating recalls, improving medical device reporting, and identifying incompatibility with devices or potential allergic reactions.
Why should you attend:
Understand how the use of a unique device identification (UDI) system may improve patient safety, e.g., by reducing medical errors, facilitating device recalls, and improving medical device adverse event reporting. Understand some of the issues associated with the use of various automatic identification technologies (e.g., bar code, radiofrequency identification). On February 26, 2004, FDA published a final rule (the ``bar code rule'') (69 FR 9120 ) requiring bar codes on certain human drug and biological products to help reduce medication errors in hospitals and other health care settings.
Areas Covered in the Session:
- Understand how to implement the Unique Device Identification
- Identify the uses and benefits of UDIs
- Understand the challenges, recommendations and proposed conclusions from multiple groups
- Review examples of Device Identification management scenarios reflecting the benefits
- Learn where the use of medical device identification encompasses four current main elements
Who Will Benefit:
This webinar will provide a general overview and update to companies who need to better understand industry's and FDA's current overview of Unique Device Identification. The employees who will benefit include:
- All end-users from appropriate departments who desire or require a better understanding and overview of Unique Device Identification and current update.
- QA and Compliance
- Regulatory Affairs and RA Specialists
- Marketing
- Consultants
- Technical Writers and employees who review labeling/tracking info
Speaker and Presenter Information
David R. Dills
Regulatory Affairs & Compliance Consultant currently provides regulatory, compliance and quality consultative services for medical device and pharmaceutical/combination manufacturers, and also has an accomplished record with more than 24 years of experience with Class I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO.
Relevant Government Agencies
Device Manufacturers
Event Type
Webcast
This event has no exhibitor/sponsor opportunities
When
Thu, Jun 30, 2016, 1:00pm - 2:30pm
ET
Website
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Organizer
Compliance4All
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