Using GS1 Standards for U.S. FDA Unique Device Identification (UDI) Workshop 

Co-Located at the 
UDI Conference 2018


This 4-hour workshop focuses on GS1 Standards within the context of the U.S. FDA Unique Device Identification (UDI) Rule.*

 

Get Ready for DSCSA With GS1 Standards

Two certificate courses to help meet one goal

Learn the principles of unique product identification and barcoding basics with GS1 Foundations. Then take the DSCSA for Suppliers course to understand how to apply GS1 Standards to meet DSCSA requirements.*

Read why AmerisourceBergen is encouraging these courses for their suppliers.

Cost: $895 (Includes bundle discount of $50)

Register Now

Enter Code ABC at check-out.

"AmerisourceBergen is delighted to partner with GS1 US on this program. It allows us to help educate our manufacturers on DSCSA regulations* and serialization standards, and will provide real value to our pharmaceutical supply chain partners.

Earn a badge - your GS1 Standards credential!

- Heather Zenk, Senior Vice President, Global Secure   Supply Chain Operations

Best Practice Guideline for Exchanging
Product Images and Data Attributes

Release 3.0 – Guideline Introduction

FREE WEBINAR

Thursday, September 28, 2017

2:00 PM - 3:00 PM (ET) Estimated Duration

 

Sponsored by:

Get Product Date Rigth the First Time
 
 

Date: Monday, April 23, 2018
Time: 1:00 PM - 5:00 PM ET
Location: Renaissance Baltimore Harborplace Hotel
202 East Pratt Street Baltimore, MD
Cost: $295.00 per person

 

Learn at Your Own Pace and Convenience

These two courses will help you meet Phase 2 of DSCSA requirements that pharmaceutical products be marked with a National Drug Code (NDC)**, serial number, lot number, and expiration date in both machine-readable and human-readable format.

  • Learn GS1 Standards basics
  • Understand DSCSA requirements
  • Effectively implement lot-level management
  • Meet serialization and item-level traceability requirements
Earn a badge - your GS1 Standards credential!

GS1 Standards: Drug Supply Chain Security Act (DSCSA) Online Certificate Course for Suppliers

Learn at Your Own Pace and Convenience

These two courses will help you meet Phase 2 of DSCSA requirements that pharmaceutical products be marked with a National Drug Code (NDC)**, serial number, lot number, and expiration date in both machine-readable and human-readable format.

  • Learn GS1 Standards basics
  • Understand DSCSA requirements
  • Effectively implement lot-level management
  • Meet serialization and item-level traceability requirements
Earn a badge - your GS1 Standards credential!

GS1 Foundations Online Certificate Course

Earn a badge - your GS1 Standards credential!

GS1 Standards: Drug Supply Chain Security Act (DSCSA) Online Certificate Course for Suppliers

Have questions on using GS1 Standards for U.S. FDA UDI?

Avoid common mistakes and receive guidance on how to use GS1 Standards for the U.S. FDA UDI Rule

Get Product Date Rigth the First Time
What GS1 Standards can be used to implement U.S. FDA UDI requirements?
How do I use GS1 Application Identifiers for my Production Identifiers?
How do I create properly formatted GS1 Global Trade Item Numbers (GTINs) for use as Device Identifiers?
What are the GS1 Standards for symbol encoding order and placement? 
What GS1 barcodes can be used for UDI?
What can I use for submitting data to the FDA Global Unique Device Identification Database (GUDID)?

Get product data right the first time

Ask yourself these six questions:

Do you know how to assign your company’s Global Trade Item Numbers (GTINs*)—aka U.P.C. barcodes—to your products?
Do you understand how package, quantity, or other product changes impact the GTIN®?
Do you do business locally or globally?
Are your manual receiving and shipping processes subject to human error? And costing you time and money?
Do you have inventory sitting in your warehouse waiting to be received, delaying your time to market, reducing your ROI?
Do you know how to handle measurement exceptions like clip strips, multiple markings, flexible packaging and such?
Get Product Date Rigth the First Time

Did you say yes to any of them? Then consider attending the new GS1 Foundations Online Certificate Course.

 

Learn how to Implement GS1 Standards
for Drug Supply Chain Security Act

The GS1 Standards: Drug Supply Chain Security Act (DSCSA) Online Certificate Course for Suppliers includes six-modules to help you apply GS1 Standards to meet DSCSA requirements.

Download the Course Flyer

 
 

Overview of GS1 Standards

Course 1 of 6 - Learn about principles of unique product identification.

How to use your company prefix

Course 2 of 6 - Learn about the GS1 and U.P.C. Company Prefix.

How to create and manage your GTIN®s

Course 3 of 6 - Learn how to identify products and create item hierarchies.
 

How to barcode your products

Course 4 of 6 - Learn which GS1 barcodes to use for your products.

Package measurement rules

Course 5 of 6 - Learn how to properly measure products, cases for accurate dimensional data.

GTIN management standard

Course 6 of 6 - Learn when a new GTIN® needs to be assigned.
 

Learn how to Implement GS1 Standards
for Drug Supply Chain Security Act

The GS1 Standards: Drug Supply Chain Security Act (DSCSA) Online Certificate Course for Suppliers includes six-modules to help you apply GS1 Standards to meet DSCSA requirements.

 
 

GS1® Overview

Module 1 of 6 – Learn more about GS1®, GS1 US, and standards use around the world.

GS1 Healthcare US® Overview

Module 2 of 6 – Learn about GS1 Standards in healthcare, the benefits, and the industry-lead initiative supporting use in the U.S.

DSCSA requirements and timeline

Module 3 of 6 – This animated video examines DSCSA requirements, compliance timelines, and responsibilities for each supply chain member.
 

Identifying DSCSA information on products

Module 4 of 6 – Learn how to apply GS1 Standards for identifying products and logistics units for DSCSA.

Capturing information for DSCSA purpose

Module 5 of 6 – This module covers GS1 barcodes used for DSCSA and capturing product information automatically across the supply chain.

Track and trace information along the supply chain

Module 6 of 6 – Learn about the GS1 Standards for sharing DSCSA information as a product moves along the supply chain.
 

Interactive, hands-on training about the use of GS1 Standards for the U.S. FDA UDI Rule


 

1. Discover how the GS1 System of Standards can be used to implement requirements of the U.S FDA UDI Rule

2. Understand the importance of data quality and the GS1 US resources available to promote data quality in your UDI implementation

3. Find out how to develop a GS1 Standards implementation plan to support your organization’s UDI implementation. 

icon-medical-devices_300-min.png


 

4. Receive a set of presentation materials for easy reference when you return to your organization

5. Network, discuss challenges, and gain insights for your implementation with peers


6. Don’t have time to travel and are still interested in UDI training? Take advantage of the: GS1 Standards for U.S. FDA UDI Online Certificate Course


 

Gain a deep understanding of the UDI Rule and what it means

 

Discover how to use GS1 Standards for your organization’s regulatory and commercial needs

Understand practices for label quality and format through hands-on exercises

Learn how to correctly apply GS1 Standards for Device Identifiers and GUDID attributes

Earn a badge - your GS1 Standards credential!

Create a directional path forward in relation to the use of GS1 Standards in your UDI work

Discuss challenges with peers and gain insights for your implementation

Advance your Class III or Class II products or preparing for Class I

 
 

Presenters

Presenter's Really-Long Name; Title, Organization

Presenter's Really-Long Name

Title, Organization

Presenter's Really-Long Name; Title, Organization

Presenter's Really-Long Name

Title, Organization

Presenter's Really-Long Name; Title, Organization

Presenter's Really-Long Name

Title, Organization

Presenter's Really-Long Name; Title, Organization

Presenter's Really-Long Name

Title, Organization

 


 
 
 

*Source: U.S. FDA Unique Device Identification System

**GS1 US is the local GS1 Member Organization that supports implementation of the GS1 System in the United States, GS1 US employees are not representatives or agents of the U.S. FDA, and the content herein has not been reviewed, approved or authorized by the U.S. FDA.

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