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Home » Education & Events » Classroom Events » 9/28/17: Using GS1 Standards for UDI Compliance - IL

9/28/17: Using GS1 Standards for UDI Compliance - IL

  • Date:Thursday, September 28, 2017 - 8:30 a.m. - 4:30 p.m. CT
  • Location:GS1 US Offices, 300 South Riverside Plaza, Suite 1400 Chicago, IL 60606
Early Bird Fee (expires September 1): $695.00 per person 
Regular Fee (after September 1): $895.00 per person

Continental breakfast and lunch will be provided

This one-day certificate course is designed for healthcare medical device manufacturers and individuals with front-line responsibility for U.S. FDA Unique Device Identification (UDI) and Global Unique Device Identification Database (GUDID).  This course 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.   
 
What You’ll Learn  
Gain a deep understanding of the UDI Rule from Issuing Agency experts.  
What the UDI Rule means and how to use the GS1 Standards for both regulatory and commercial needs of their company.  
Directional path forward in relation to the use of GS1 Standards in your UDI work. 

Who Should Attend

Medical device manufacturers and distributors with responsibility for UDI implementation in their organizations.

Content:  The session will focus on a detailed level understanding of the following and is intended to be interactive throughout:

  • GS1
    • Who is GS1
    • Issuing Agency
    • What is AI
      • How to include in a bar code
    • What is a bar code
      • Types of bar codes
      • Restrictions on bar codes (UPC versus GS1-128)
    • Relevant Guides, Standards, Posters, and Use Cases
    • Use of GTIN and AIs for UDI
      • Common healthcare AIs
      • Common bar codes for healthcare
    • Data Pool selection
    • GUDID live review
  • GTIN
    • What is a GTIN
      • What is a prefix
      • How to construct a GTIN
      • GTIN Allocation Rules
  • UDI
    • What is a UDI
      • UDI Allocation Rules
  • Package Hierarchy
    • What is a hierarchy
    • Why would a hierarchy be used
    • Hierarchy examples
  • GDSN
    • What is GDSN
      • Parties involved
      • Message flow
  • GUDID
    • What is GUDID
    • What are the GUDID attributes
    • GDSN to GUDID
      • Mapping
      • Data flow
  • Intro to other workshops and services available from GS1 US
    • All Day Onsite Workshop
    • Advisory Services
    • Review of participant product examples

The top 10 reasons you should attend the GS1 US GS1 Standards: UDI Certificate Course
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 certificate course, 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 hierarchies – Find 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.

Location

GS1 US Offices
300 South Riverside Plaza, Suite 1400
Chicago, IL 60606


Chicago area hotels with GS1 US negotiated rates

Courtyard Marriott Magnificent Mile
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Rate 249.00 USD

Crowne Plaza Metro Downtown
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Rate 129.00 USD/178.00 USD

Residence Inn Marriott River North
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Rate 129.00 USD

Springhill Suites Marriott Downtown
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Wyndham Grand Chicago Riverfront
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Due to the overwhelming hotel demand and high occupancy rates, hotel rooms and GS1 US preferred rates are always subject to availability.

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