FDAnews
Falls Church, VA (PRWEB) August 20, 2014
What to Do Now for UDI:
Don’t Lose Your Customers by Getting Locked Out of the Market
**FDAnews Webinar**
Sept. 11, 2014 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/DoNowforUDI
Hospitals and other buyers of devices lose $5 billion or more each year due to ineffective product tracking systems.
Complying with the FDA’s deadlines is important, but even more important is customer demands to implement UDI as soon as possible. If devicemakers don’t, they’ll be losing business to 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.
On Sept.11, attend the FDAnews webinar 7 Things to Do Now for UDI: Don’t Lose Your Customers by Getting Locked Out of the Market.
Expert webinar leaders Dan O’Leary and Donald Guthner will teach attendees what they must do ASAP and provide them with invaluable handouts to begin the UDI conversion process, to stay on track, and to keep a tight grip on hospital customers during the transition.
In just 90 minutes, attendees will get must-know details about:
- Understanding customers' needs in the new era of UDI
- Distinguishing among Identification, Tracking, and Tracing
- Dealing with an accredited agency: devicemakers should start now
- The data elements required for FDA’s global database (GUDID)
- Locating the data for GUDID: possibly the biggest scavenger hunt in a company’s history
- Loading data for GUDID: devicemakers have significant decisions to make
- Understanding the concepts of data integrity: is Part 11 needed?
- Understanding where the DI goes on a product: label, package, and direct marking
- Forming the UDI means decoding on the optional elements, i.e., the production identifiers
- Changes required to the Quality Management System including QSR, MDRs, etc.
- And more
EXCLUSIVE BONUSES: During the session, attendees will receive these invaluable handouts: a UDI implementation model, including a Work Breakdown Structure, to help understand the time restraints and requirements devicemakers are under, a checklist that details how UDI implementation impacts various parts of a 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 devicemakers must prepare for it ASAP. Plan now to attend 7 Things to Do Now for UDI: Don’t Lose Your Customers by Getting Locked Out of the Market on Sept. 11, 2014.
Meet the 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.
Who Will Benefit:
- Regulatory Managers
- Design Engineers
- Labeling Specialists
- Project Managers
- Quality Managers
- Quality Engineers
- Executive management
- R&D staff
- Strategic planning staff
Webinar Details:
What to Do Now for UDI:
Don’t Lose Your Customers by Getting Locked Out of the Market
**FDAnews Webinar**
Sept. 11, 2014 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/DoNowforUDI
Tuition:
$487 per site -- includes webinar registration and audio cds and transcripts
Easy Ways to Register:
Online: http://www.fdanews.com/DoNowforUDI
By phone: 888-838-5578 or 703-538-7600
About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.