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Home » Education & Events » Classroom Events & Workshops » 3/30/17: Using GS1 Standards for UDI Compliance - IL

3/30/17: Using GS1 Standards for UDI Compliance - IL

  • Date:Thursday, March 30, 2017 - 8:30 a.m. - 4:30 p.m. CT
  • Location:10 S. Riverside Plaza, Suite 840, Chicago, IL, 60606
Early Bird Fee (expires March 17): $695.00 person
Regular Fee (after March 17): $895.00 per person 

Continental breakfast and lunch will be provided

This one day workshop is designed for healthcare medical device manufacturers and individuals with front-line responsibility for FDA Unique Device Identification (UDI) and Global Unique Device Identification Database (GUDID).  This workshop will focus on the use and implementation of the GS1 Standards including Global Trade Item Number® (GTIN®) and the Global Data Synchronization Network™ (GDSN®) as a method to identify medical devices with a UDI number and bar code and to load the GUDID with device information.   
 
Why attend?  
To gain a deep understanding of the UDI Rule from Issuing Agency experts.  The user will leave the workshop being able to effectively describe what the UDI Rule means and how to use the GS1 Standards for both regulatory and commercial needs of their company.  The user will be provided with a directional path forward in relation to the use of GS1 Standards in their UDI work.

GS1 System Overview
  An overview of GS1 Standards and how to leverage for global, local and cross-industry business needs
FDA Unique Device Identification (UDI)
  Details about the FDA UDI System including compliance requirements, dates and exceptions or extensions for select medical devices.
GS1 Standards in Depth
 IDENTIFY: Global Trade Item Number® (GTIN®) and FDA Device Identifier (DI) and Production Identifier (PI)
 In depth instruction on Identification, Construction, Assignment, Hierarchy, Allocation
 CAPTURE: Automated Information Data Capture (AIDC) Standards
 Learn about the key barcodes used in healthcare and when they can be used in certain business applications 
 SHARE: Global Data Synchronization Network™ (GDSN®) and the FDA Global Unique Device Identification Database (GUDID)
 The basics of the GS1 GDSN and the FDA’s GUDID; includes a review of required and optional GUDID attributes
Implementation Readiness
  An overview of the elements of a successful UDI Program

How to Use GS1 Standards for UDI Workshop: What’s in it for you?

The top 10 reasons you should attend the GS1 Healthcare US Group Workshop: Using GS1 Standards for UDI Compliance

You have the responsibility of managing Unique Device Identification (UDI) requirements within your organization. With the goal of complying while also enhancing patient safety and supply chain efficiencies, UDI also represents a major opportunity for industry collaboration and the streamlining of business processes both internally and externally with your trading partners.

By attending the workshop, you will bring valuable UDI and standards knowledge back to your company and enhance your own professional development.

You will learn:

  1. How to interpret labeling requirements – Will your existing barcode satisfy UDI requirements? Find out more about this and other labeling best practices.
  2. The basics of UDI Terms – Add important acronyms to your vocabulary and use them fluently, like Global Trade Item Number (GTIN), application identifiers (AI), and Global Unique Device Identification Database (GUDID).
  3. The latest on GUDID activity – Learn what information has to be submitted to the GUDID and in what format.
  4. How to use the GDSN – Learn why many healthcare companies are finding that synchronizing data via the Global Data Synchronization Network™ (GDSN®) is a valuable method to identify medical devices and share product attributes. 
  5. Ways to map GDSN information to the GUDID – Find out how the GDSN can help streamline your data submissions to the GUDID.
  6. Who needs to be involved and why – Regulatory teams, supply chain teams, master data teams and more should be involved in UDI decision making. Learn the valuable roles everyone plays within your organization in UDI implementation and beyond.  
  7. Participant examples – Real world lessons learned will be shared and attendees will discuss with their peers how to apply standards to their own products and processes.
  8. Packaging hierarchiesFind out what the appropriate UDI data carriers are for each level of packaging.
  9. Repackaging and relabeling rules– Attendees will learn at what point a new UDI is needed.
  10. How to gain a competitive advantage – Consider UDI beyond compliance—learn how GS1 Standards benefit companies who trade internationally and how product and inventory visibility brings a host of benefits through improved efficiencies and patient safety.

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Registrant's Information

$695.00