FDAnews Announces Top 9 UDI Compliance Challenges: Former FDA UDI Chief Provides Answers, Webinar, March 11, 2014

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Jay Crowley, the man who wrote the FDA UDI rule, will lead an in-depth 90-minute webinar focusing on what he views as the top 9 challenges that devicemakers face in complying with the final rule. Implementation is mandated in stages over the next few years, but most companies are nowhere near compliance.

Top 9 UDI Compliance Challenges:
Former FDA UDI Chief Provides Answers
**FDAnews Webinar**
March 11, 2014 — 1:30 p.m. – 3:00 p.m. EDT

For most device manufacturers, it's their first opportunity to get up close and personal with what the FDA is requiring of them in the coming years.

To help, Mr. Crowley has identified the following 9 questions as the key challenges for the industry, and will provide implementation tips, best practices and in-depth answers to them:

1. What if there is a manufacturing date on the label? Does it need to be included? Many manufacturers put a date on the label — but don’t use it for control purposes and don’t want to put it in UDI. But now it’s the law.

2. What day should be used in the standardized date format? Some manufacturers have never included day in the expiration date; using only year and month. But the final rule requires that a specific day be included.

3. What is the correct Global Medical Device Nomenclature (GMDN) term for a device or combo product?

4. How should manufacturers select the proper LABELER Data Universal Numbering System (DUNS) for businesses globally?

5. Manufacturers are confused about implantable devices. Are extended wear contact lenses implants?

6. How should manufacturers handle some of the most complex compliance challenges, such as kits, convenience kits and combination products?

7. How far reaching is the UDI requirement? For example, what are the requirements for orthopedic trays?

8. What is the secret to understanding and navigating all of this packaging hierarchy?

9. At which point in the process does it make the most sense to assign a new device identifier?

It's no exaggeration to say that the FDA’s UDI rule impacts every device company and applies to multiple parts of each organization’s quality systems. This is not a rule that can be overlooked.

Sign up now to attend and receive these invaluable documents to help with the transition to the new rule:

  •     The slide deck from Mr. Crowley’s presentation
  •     A complete collection of FDAnews articles focusing on the UDI rule
  •     Full text of FDA’s Unique Device Identification System Final Rule
  •     FDA’s Global Unique Device Identification Database (GUDID) Draft Guidance
  •     International Medical Device Regulators Forum's revised document on the Unique Device Identification (UDI) System for Medical Devices

SPECIAL BONUS: Devicemakers may not be sure their company will be ready by the FDA’s published deadlines. The first deadline could be as soon as Sept. 24, 2014. There is a way to apply for exemptions, extensions or alternatives, but manufacturers must understand the right way to approach the FDA. In this bonus take-away, Mr. Crowley will explain how.

Regsister for Top 9 UDI Compliance Challenges: Former FDA UDI Chief Provides Answers? Attendees will get an insider's understanding of the complex nuances of UDI, detailed answers to their toughest questions and tips to help with implementation. If there has ever been a "must attend" webinar, this is the one!

Meet Your 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:

  •     Manufacturing and compliance professionals
  •     Supply chain professionals
  •     Quality assurance and quality control professionals
  •     Regulatory affairs
  •     Consultants
  •     Contractors/subcontractors

Conference Details:
Top 9 UDI Compliance Challenges:
Former FDA UDI Chief Provides Answers
**FDAnews Webinar**
March 11, 2014 — 1:30 p.m. – 3:00 p.m. EDT

$547 per site -- includes webinar registration and audio cds and transcripts

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