FDAnews Announces What to Do Now for UDI: Dont Lose Your Customers by Getting Locked Out of the Market Webinar, Sept. 9, 2014 - WCIV-TV | ABC News 4 - Charleston News, Sports, Weather

FDAnews Announces What to Do Now for UDI: Dont Lose Your Customers by Getting Locked Out of the Market Webinar, Sept. 9, 2014

Posted:

This article was originally distributed via PRWeb. PRWeb, WorldNow and this Site make no warranties or representations in connection therewith.

SOURCE:

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. Expert webinar leaders Dan OLeary 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.

Falls Church, VA (PRWEB) August 20, 2014

What to Do Now for UDI:
Dont 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 FDAs deadlines is important, but even more important is customer demands to implement UDI as soon as possible. If devicemakers dont, theyll 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: Dont Lose Your Customers by Getting Locked Out of the Market.

Expert webinar leaders Dan OLeary 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 FDAs global database (GUDID)
  •     Locating the data for GUDID: possibly the biggest scavenger hunt in a companys 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 companys 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: Dont Lose Your Customers by Getting Locked Out of the Market on Sept. 11, 2014.

Meet the Presenters:
Dan OLeary 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 Masters 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:
Dont 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.

For the original version on PRWeb visit: http://www.prweb.com/releases/FDAnews/DoNowforUDI/prweb12103301.htm

Information contained on this page is provided by an independent third-party content provider. WorldNow and this Station make no warranties or representations in connection therewith. If you have any questions or comments about this page please contact pressreleases@worldnow.com.

Powered by WorldNow

ABCNews4 WCIV-TV

888 Allbritton Dr.
Mt. Pleasant, SC 29464
843-881-4444 | Advertising Information

Public Information File

For assistance with accessing WCIV-TV's public information file, click here.

Advertising

Advertising Credit Application and Terms and Conditions PDF.

Powered by WorldNow
All content Copyright © 2014 WCIV and Worldnow. All Rights Reserved.
For more information on this site, please read our Privacy Policy and Terms of Service.