FDAnews Announces: How to Implement UDI: Lessons from Early Adopters Webinar, May 20, 2015

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UDI deadlines are coming fast for all devicemakers and soon the FDA will demand compliance. FDAnews has asked the man who helped write the rule, Jay Crowley, former Senior Advisor for Patient Safety in the Food and Drug Administration's Center for Devices and Radiological Health, to host this 90-minute webinar on how to implement UDI.

How to Implement UDI:
Lessons from Early Adopters
**FDAnews Webinar**
May 20, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/HowToImplementUDI

With all the extensions, special exemptions, and promises of regulatory restraint, there’s plenty of time to get ready for the FDA’s UDI rule deadlines, right? Think again. UDI deadlines are coming fast for all devicemakers and soon the FDA will demand compliance.

Don’t delay, even if it seems there’s no rush. It's already clear that implementation and compliance with this new rule is a big challenge. Devicemakers will need to understand what UDI is, who it applies to, what the exceptions to the rule are, what deadlines must be met, what UDI-issuing agencies are, and how to work with them.

Thankfully, help is here. FDAnews has asked the man who helped write the rule, Jay Crowley, former Senior Advisor for Patient Safety in the Food and Drug Administration's Center for Devices and Radiological Health, to host this 90-minute webinar on how to implement UDI.

Since leaving the agency, Jay has worked with USDM Life Sciences, consulting with companies to get their UDI systems up to speed and working. Jay’s seen the UDI requirements from both sides, and what he’s learned in the early days of UDI adoption will potentially save attendees from some of the headaches experienced by companies that have already implemented UDI.

Attendees will learn:

  • The difference between UDI and track and trace;
  • The timetable for implementation for Class I, Class II and Class III devices;
  • Which devices must comply with the rule and which are exempt;
  • What information must be included on product labels;
  • How to submit device identification information to the GUDID;
  • About the accredited UDI-issuing agencies, their roles (and how to become one);
  • The benefits of UDI to industry, regulators and the public;
  • 10 key lessons early adopters learned the hard way
  • And much more….

How to Implement UDI: Lessons from Early Adopters will jump start UDI implementation and get devicemakers off on the right foot today.

Meet the Presenter:
Jay Crowley led the FDA team that wrote the UDI rule. As Senior Advisor for Patient Safety for CDRH, Mr. Crowley developed the framework and authored key requirements for the FDA's UDI requirements.
In December 2013, after a 27-year FDA career, Mr. Crowley became a VP of the UDI practice at USDM Life Sciences. USDM is a leading global professional services firm focused exclusively on providing business process, technology and compliance solutions for the regulated life science industry. USDM's professionals are recognized thought leaders in emerging life science computer system topics. They are experts in improving business value through the implementation and adoption of new technologies that run regulated business processes.

Who Will Benefit:

  • Regulatory Managers
  • Design Engineers
  • Labeling Specialists
  • Project Managers
  • Quality Managers
  • Quality Engineers
  • Executive Management
  • R&D Staff
  • Strategic Planning Staff

Conference Details:
How to Implement UDI:
Lessons from Early Adopters
**FDAnews Webinar**
May 20, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/HowToImplementUDI

Tuition:
$287 per site

Easy Ways to Register:
Online: http://www.fdanews.com/HowToImplementUDI
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.

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Michelle Butler
FDANEWS
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