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UDI: The Ins and Outs of Global Compliance and Value (OMTEC 2015)

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Read this, too: How to Uncover and Overcome UDI Challenges Facing Orthopaedics

Orthopaedic device manufacturers are among the first required to comply with FDA's Unique Device Identification (UDI) rule, with global suppliers facing further regulation from other international bodies developing their own versions of the rule. Join UDI experts as they provide the latest information on the status of the regulation in the U.S. and elsewhere, specific challenges faced by the orthopedic industry and ways that manufacturers can leverage the regulation to create both value and savings for their organizations and their customers.

Karen Conway recaps UDI challenges unqiue to orthopaedics and shares why OEMs will benefit from OMTEC.


Session Takeaways

  • Overview of approaching U.S. deadlines and best practices to meeting them
  • Understanding of ways to handle situations yet to be defined by FDA
  • Update on forthcoming global UDI regulations

Who Should Attend

  • Product Management
  • Supply Chain Management
  • Regulatory and Clinical Affairs
   
Speaker Bios Prepare for this Session
Karen-Conway 2015 WEBAs executive director for industry relations at GHX, Karen Conway works internationally with standards bodies, government agencies, analysts and academic researchers, industry associations, and both suppliers and their customers to identify opportunities to optimize supply chain operations and improve business and clinical performance.

Prior to joining GHX, Ms. Conway served as principal of Conway Associates, a strategic communications firm built on the principles of continuous quality improvement. She has also worked as a journalist and in government and regulatory affairs.

Ms. Conway is co-author of Leading from the Edge and a contributing author for the book, e-Business in Healthcare.

Ms. Conway serves on the boards of directors of AHRMM, the supply chain organization for the American Hospital Association, and the Arizona State University Health Sector Supply Chain Research Consortium. She also co-chairs the HIMSS Supply Chain Special Interest Group and is active in the Medical Device Supply Chain Council and the Strategic Marketplace Initiative (SMI).
11 Questions OEMs Must Ask During UDI Preparation
  1. Which products will be covered by UDI and when?
  2. Is production manual or automated?
  3. Where are those products produced?
  4. Into which markets are they sold?
  5. Will the label artwork have enough space to accommodate the UDI?
  6. Do you need to add printing capabilities to accommodate dynamic (production) data? If so, how will that impact space and layout on the production floor?
  7. How will you handle validation of new IT equipment and processes?
  8. Do you have kits or combo products? If so, you do label each of them late-stage and then combine?
  9. Do you have multipacks? Will secondary or tertiary labeling be required?
  10. Do you have any products that are implanted longer than 30 days or that must be re-sterilized before reuse, and may require direct part marking?
  11. Will you need to add a contingent workforce to prepare for UDI?

Read the entire article, UDI Update: Prepping for the Final Ruling, as well as comprehensive coverage of  UDI requirements and steps for implementation.

JayCrowley webJay Crowley is Vice President of Unique Device Identification Solutions and Services at USDM Life Sciences. Prior to his current role, Mr. Crowley served as Senior Advisor for Patient Safety in FDA’s Center for Devices and Radiological Health, where he developed the framework and authored key requirements for the UDI system.

At USDM Life Sciences, Mr. Crowley focuses exclusively on providing business process, technology and compliance solutions for the regulated life science industry.

Mr. Crowley held a variety of positions over his nearly 27 years at FDA, including work with design control regulations to reduce the chance of human errors with medical devices, patient safety and adverse event reporting. Mr. Crowley also worked in the Office of the Commissioner of FDA, and the Office of Compliance at FDA.