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EVENT UPDATE: This event will be rescheduled, look for a new date  announced soon!

 
The UDI Rule has been released: 
What should you expect for implementation?
 
Industry Networking and Educational Seminar
 
 
Due to feedback and response rate we've received, 
this event has been postponed but will be rescheduled to a new date in the near future.
 
We would like to hear from you on how we can make this event better for the new date. Please take a minute to give us your feedback - we assure you, every response will be read.
 
Please give us your feedback, brief survey HERE:
https://www.surveymonkey.com/s/QGPPYRC
 
Thank you & and we sincerely apologize for any inconvenience.
  
  
 
 
The Final UDI Rule was released in the Code of Federal Regulations on September 24, 2013. This Rule pertains to unique device identification requirements for all medical devices. These requirements pertain to package labeling and direct part marking as well as the UDI database [GUDID].
In this seminar we will review some of the most critical requirements and impacts to medical device manufacturers and to the industry.
 
Experienced speakers will cover key topics:
* FDA's Final Rule on UDI: Changes from the proposed Rule to Final Rule and important details in the Final Rule
* Impacts related to your choice of Issuing Agency
* Industry challenges presented by the UDI Rule
* How the UDI requirements will impact manufacturers
 
  
Agenda 
4:30 - 5:30PM Registration & Social Reception 
  
5:30 - 6:15PM Dinner
  
6:15 - 8PM  Presentations
  
8-8:30PM Q&A Session
  
Jay Crowley, Senior Advisor for Patient Safety in FDA's Center for Devices and Radiological health, U.S. Food and Drug Administration (FDA),
will review the background of UDI and will address the requirements in the final rule.
 
MJ Wylie, GS1 U.S. Sr. Director, Healthcare,
will discuss the impact your chosen "Accredited Issuing Agency" will play in your UDI implementation.
 
Gerry Gunderson, VP of Engineering at Quality Tech Services, will provide a perspective from the manufacturing environment.  UDI is not ''just a barcode'' and Manufacturers' compliance will require effort on several fronts including: Developing, imprinting and verifying compliant package barcodes, as well as Direct Part Marking (DPM). 

Are you prepared to deal with the impacts of UDI to your business?
  
 
Please give us your feedback for the next event - brief survey here:
 

 

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Chapter Sponsors
Click on a business card to open new browser of sponsor's web page:


algrant@optonline.net
 
http://www.tek.com/contact-us
or jean.gerisch@tektronix.com
Primme
Superior

We are pleased to continue our sponsor section as another member benefit.  E-Business card ads are linked to your website. The cost is $125/year (a great value compared to most advertising alternatives.) All we need a business card size file (approx 3.5" x 2") in jpeg, tiff, bmp or similar format. 
Please contact us if you would like to become a sponsor and have any questions.

Updated: 16 Nov 2013  MRE