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
• 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:
- How to interpret labeling requirements – Will your existing barcode satisfy UDI requirements? Find out more about this and other labeling best practices.
- 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).
- The latest on GUDID activity – Learn what information has to be submitted to the GUDID and in what format.
- 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.
- Ways to map GDSN information to the GUDID – Find out how the GDSN can help streamline your data submissions to the GUDID.
- 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.
- 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.
- Packaging hierarchiesFind out what the appropriate UDI data carriers are for each level of packaging.
- Repackaging and relabeling rules– Attendees will learn at what point a new UDI is needed.
- 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.