Tips for Implementing FDA UDI without Derailing Production
- Experts share advice on improving patient safety with Unique Device Identification without throwing your organization off track -
Date: Tuesday, June 29, 2010
Speakers: Jay Crowley, FDA and Janice Kite, GS1 Global Office
View the recorded session
Benefits from the webinar:
- Gain an understanding of FDA UDI rule in practical terms
- Walk through the planned timeline for proposed FDA UDI regulations
- Evaluate the benefits of implementing bar-coding using GS1 standards
- Understand how labeling systems can remove the perceived complexities of FDA UDI regulations
- Learn how to implement UDI with minimal impact on your organization
For the sake of patient safety, the ability to track and trace medical devices at a global level is paramount. Currently there is no single global regulation for uniquely identifying medical devices in the supply chain. This means recalling devices is less efficient and more complex than it could and should be, negatively impacting patient safety and confidence.
The FDA’s mandate for UDI (Unique Device Identification) for medical devices offers a way of presenting information in a standard format or barcode, making trade, distribution and usage more secure. Compliance, however, can prove to be a time-consuming process, and if done incorrectly, can expose your company to serious setbacks. Aligning yourself with the FDA UDI regulations will impact many areas within your organization and will involve changes to current products and procedures, including:
- required elements in label design,
- necessary software and hardware,
- the uptake of barcode standards.
‘Tips for Implementing UDI without Derailing Production’ . In this 60-minute, information-packed session, PRISYM ID was joined by industry experts Jay Crowley, FDA, and Janice Kite, GS1 Global Office, and gave an in-depth look into how to plan and implement UDI strategy with minimal impact on organizations.
About the webinar presenters:
 Jay Crowley, FDA
Jay Crowley is a Senior Advisor for Patient Safety in the FDA’s Center for Devices and Radiological Health. He is interested in developing and implementing new methods and techniques for identifying and resolving problems with the use of medical devices. Jay has held a variety of positions over his 20 years at the FDA. Currently, Jay has responsibility for implementing the Unique Device Identification requirements of the 2007 FDA Amendments Act. He holds a master’s degree in risk analysis and a bachelor’s degree in mechanical engineering.
Janice Kite, GS1 Global Office
Prior to joining GS1 Global Office as a consultant in 2007, Janice was a senior manager with responsibility for eBusiness for Johnson & Johnson’s UK Medical Device and Diagnostic companies. Janice was Chair of the Association of British Healthcare Industries (ABHI) Supply Chain and eBusiness Group (SCEBG) and Vice-Chair of Eucomed’s (The European Medical Technology Industry Association) eBusiness Task Force (ETF), founding Co-Chair of GS1 UK Healthcare User Group; and she is Vice-Chair of Henley Alumni’s Healthcare Special Interest Group.
Chris Miller, PRISYM ID Limited
Chris Miller joined PRISYM ID in 2009 to assist the company in building on its success within the US Life Sciences market. Previously Chris was the Director of Worldwide Sales for a medical device company where he led the commercialization of a novel breast cancer detection modality. In this capacity, Chris enabled over $3 million in sales by building and supporting a global sales channel. Chris also assisted with the 510(K) approval, 21CFR Part 11 compliance, the Australian Register of Therapeutic Goods (ARTG) registration, and Canada Medical Device Regulations CMDR compliance.
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For more information contact PRISYM ID Marketing at:
 info at prisymid dot com or call UK (+44)(0) 118936 4400
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FDA UDI webinar
