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FDAnews Announces The FDA Unique Device Identification (UDI) Rule Virtual Conference

Falls Church, VA (PRWEB) November 04, 2013

The FDA Unique Device Identification (UDI) Rule
It’s Ready for You, Are You Ready for It?
**FDAnews Virtual Conference**
Nov. 19, 2013 — 10:00 a.m. – 4:00 p.m. EST

Less than a year from now, all class III devicemakers will have to comply with FDA’s new UDI rule. Deadlines for other device classes follow in lockstep.

That may sound like plenty of time. It isn't.

This single requirement stretches across the entire operation, from creating adequate production and device identifier systems to labeling, marketing, packaging and adverse event reporting. Devicemakers need to identify as many as 55 data elements just to generate a UDI. It’s not simple.

Every change will also have to be incorporated in the SOPs and all employees trained.

Hospitals and purchasers are already updating their systems — and they’ll expect the companies they buy from to be ready, too.

In just one fast-paced day, attendees will hear from five of the top experts on UDI, including the man who wrote the rule; an early-adopter who’s implemented UDI and can tell attendees mistakes to avoid; a healthcare provider who can tell attendees exactly what their needs are; and consultants who are working with companies to implement UDI. The lineup includes:

  •     Jay Crowley, Senior Advisor for Patient Safety, CDRH, FDA
  •     Jackie Rae Elkin, Global Process Owner, Medtronic
  •     Rosalind Parkinson, Chief Supply Chain Officer, The Ohio State University, Wexner Medical Center
  •     Dan O’Leary, President, Ombu Enterprises LLC
  •     Donald Guthner, Principal, Orgenix, LLC

Click here to view the full agenda

The virtual conference is convenient to attend. All that’s required is that attendees be in front of a computer screen at the appointed time, whether they at the office or telecommuting from their office-in-home.

Of course, the panel of experts will be on hand to answer questions. Simply submit questions via email, and they will be answered by the time the session ends.

Everyone in with a role in product development, legal and regulatory affairs will benefit from taking part in this event — and they can do so at a cost that won’t break the budget. Companies pay a single low registration fee per line, regardless of how many participate. So spread the word.

Sign up for The FDA Unique Device Identification (UDI) Rule: It’s Ready for You, Are You Ready for It? virtual conference today.


  •     Product development teams
  •     R&D and engineering
  •     Risk management and design operations
  •     Manufacturing executives
  •     QA/QC staff
  •     Compliance officers
  •     Executive management
  •     Legal and regulatory affairs
  •     Outside counsel

The FDA Unique Device Identification (UDI) Rule
It’s Ready for You, Are You Ready for It?
**FDAnews Virtual Conference**
Nov. 19, 2013 — 10:00 a.m. – 4:00 p.m. EST

$1,297 per site -- includes virtual conference registration and audio cds and transcripts

By phone: 888-838-5578 or 703-538-7600

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.

Read the full story at

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