What to Do Now for UDI - Webinar CD/Transcript

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What to Do Now for UDI: Don’t Lose Your Customers by Getting Locked Out of the Market

Hospitals — and other buyers of devices — lose $5 billion or more each year due to ineffective inventory management systems.

Compiling with the FDA’s deadlines is important, but even more important is your customer’s demands to implement UDI as soon as possible.  If you don’t, you’ll be losing business to your UDI-ready competitors.

The new UDI regulations — with implementation starting in 2014 (first phase must be completed by Sept. 24, 2014) — will allow hospitals to improve compliance, patient safety and modernize inventory.

Your customers are ready for UDI, are you?

Our expert leaders Dan O’Leary and Donald Guthner teach you what you must do ASAP and provide you with invaluable handouts to begin your UDI conversion process … to stay on track … and to keep a tight grip on your hospital customers during the transition.
 In just 90 minutes, you'll get must-know details about:

  • Understanding your customers' needs in the new era of UDI
  • Distinguishing among Identification, Tracking, and Tracing
  • Dealing with an accredited agency: you should start now
  • The data elements required for FDA’s global database (GUDID)
  • Locating the data for GUDID: possibly the biggest scavenger hunt in your company’s history
  • Loading data for GUDID: you have significant decisions to make
  • Understanding the concepts of data integrity: do you need Part 11?
  • Understanding where the DI goes on your product: label, package, and direct marking
  • Forming the UDI means deciding on the optional elements, i.e., the production identifiers
  • Changes required to your Quality Management System including QSR, MDRs, etc.
  • And more

EXCLUSIVE BONUSES: You'll receive these invaluable handouts: a UDI implementation model, including a Work Breakdown Structure, to help your company understand the time restraints and requirements you are under … a checklist that details how UDI implementation impacts various parts of your company’s Quality Management System … a key Excel file that describes the GUDID attributes … and a complete copy of the final GUDID guidance.
There's no turning back. UDI is coming and you must prepare for it ASAP.

  • Regulatory Managers
  • Design Engineers
  • Labeling Specialists
  • Project Managers
  • Quality Managers
  • Quality Engineers
  • Executive management
  • R&D staff
  • Strategic planning staff

Meet Your Presenters
Dan O’Leary has more than 30 years of experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. Dan is President of Ombu Enterprises, LLC a consultancy focused on operational excellence and regulatory compliance serving small manufacturing companies. He has a Master’s Degree in Mathematics; is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.

Don Guthner has more than 30 years of industry experience working with FDA, most recently as the founder and Principle of Orgenix, LLC, a regulatory and clinical CRO. Mr. Guthner has a strong background in designing and conducting multi-center clinical trials with medical device products as well as having successful PMA and 510(k) submissions of medical devices to FDA.  He has coordinated the world-wide registration of medical devices, including Europe and Asia.