Are You Done with UDI?
Or Is This Just the Beginning?
FDA and Industry Experts Discuss Leveraging UDI
to Accelerate Product Quality and Safety

Recorded Oct. 13, 2016
An FDAnews FREE Webinar

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You should be ready to comply with UDI by now — but that’s only the beginning.

Hear directly from FDA’s Senior Advisor for UDI and Industry Experts the profound effect UDI implementation will have on med-tech manufacturers, healthcare providers, regulators and ultimately the patient.

Join Terrie Reed, Senior Advisor for UDI Adoption at the FDA, Daniel R. Matlis of Axendia, and Jean Colombel of Dassault Systemes on Oct. 13 as they discuss UDI and how its value resides in the ability to optimize meaningful data collection and analysis.

After attending this 60-minute webinar, you will understand:

  • FDA’s intent to significantly improve device evaluation and decision-making through the adoption of unique device identification (UDI) across the device ecosystem.
  • The possibilities of UDI — opportunities to go beyond compliance and leverage UDI for the future
  • The implications for patients, providers and manufacturers in leveraging UDI information in global regulatory strategies
  • The value of managing the device identifier (DI) & production identifier (PI) throughout the product lifecycle
  • Effects of UDI implementation in terms of post-market quality management and future innovation efforts including precision medicine initiatives
  • Why a platform approach drives harmonization within global operations and helps companies proactively manage quality and regulatory strategies

Once UDI is fully implemented as part of a company’s global business operation, the opportunities for improving quality, streamlining regulatory reporting, and ultimately driving innovations forward are finally possible.

Who Will Benefit

  • Regulatory Affairs
  • Quality Assurance
  • Engineering, R&D
  • Project Managers, Program Managers
  • Safety
  • Risk Management
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Meet Your Presenters

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Terrie Reed

Senior Advisor for UDI Adoption
FDA

Terrie has spent her career advocating for the operational integration of data standards and informatics principles into healthcare and government systems in order to improve the efficiency of regulatory submissions and public health reporting. Her latest role as Senior Advisor for UDI Adoption is the culmination of years of systems analysis, information science, and regulatory science experience aimed at significantly improving device evaluation and decision-making through the adoption of unique device identification (UDI) across the device ecosystem.

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Daniel R. Matlis

Founder and President
Axendia

Dan has over 25 years of experience in the Industry spanning the entire value chain. He has been involved in projects covering R&D, Commercial Operations, Regulatory Compliance, Business Development and Information Technology. Dan is an active member in the FDA’s Case for Quality Initiative and has presented Axendia’s research findings to industry executives and the FDA.

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Jean Colombel

Vice President, Life Sciences Industry
Dassault Systèmes

His organization is responsible for creating and developing Dassault Systèmes strategy and associated solutions for pharmaceutical, medical device and healthcare industry segments. Since joining the company in 2009, Jean has grown the Life Sciences business significantly and further enhanced the product portfolio by working closely with leading corporations, global regulatory agencies and various hospital organizations, while partnering and acquiring multiple business operations.