Current State: Data Quality and U.S. FDA Unique Device Identification


FREE WEBINAR


Learn about the impact and importance of Data Quality and U.S. FDA Unique Device Identification.

 

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

GS1 Standards for the Drug Supply Chain Security Act for Suppliers Certificate Course

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
 
 

Featured Speakers:

  • Beth Gibson, Sr. Director Industry Development, Medical Device, GS1 US

  • Carrie L. Tozzi, Director, Product Management, GS1 US

  • Behnaz Minaei, FDA-CDRH-Informatics Team

 

The Impact and Importance of Data Quality and U.S. FDA Unique Device Identification 

GS1 US is committed to helping the healthcare industry assign consistent, accurate, and properly structured Global Trade Item Numbers (GTINs). This month’s free, open industry webinar will provide attendees with: 

  • An update on the current state of data quality within the Global Unique Device Identification Database (GUDID) and the impact of poor data quality 
  • An overview of the GS1 US Data Hub® | Product tool, which industry stakeholders are encouraged to use to assist them in accurately assigning and managing GTINs
  • An update on the two most recently published U.S. FDA Guidance documents (Nov 2017 Direct Mark and Jan 2018 Compliance Date for Class 1 Devices)
Earn a badge - your GS1 Standards credential!

Current State: Data Quality and U.S. FDA Unique Device Identification


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

Get product data right the first time

Ask yourself these six questions:

Get Product Date Rigth the First Time
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?

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

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.
 

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.

 

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Aliquam eget mollis mi, at convallis tellus. In blandit, sapien non venenatis efficitur, ipsum tellus.
 

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.

 

1. Lorem ipsum dolor sit amet

Aliquam eget mollis mi, at convallis tellus. In blandit, sapien non venenatis efficitur, ipsum tellus.

2. Lorem ipsum dolor sit amet

Aliquam eget mollis mi, at convallis tellus. In blandit, sapien non venenatis efficitur, ipsum tellus.

3. Lorem ipsum dolor sit amet

Aliquam eget mollis mi, at convallis tellus. In blandit, sapien non venenatis efficitur, ipsum tellus.
Earn a badge - your GS1 Standards credential!
GS1 Foundations Online Certificate Course

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Aliquam eget mollis mi, at convallis tellus. In blandit, sapien non venenatis efficitur, ipsum tellus.

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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

 

*For more information about the rule, see the U.S. FDA Unique Device Identification System
Disclaimer: 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 FDA.

 
 
 

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

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