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Home » Certificate Courses » Online Education » DSCSA Supplier » GS1 Standards for DSCSA Suppliers Online Certificate Course

GS1 Standards for DSCSA Suppliers Online Certificate Course

  • Date:Online Course
  • Location:GS1 US Learning Management System (LMS)

Are you a pharmaceutical manufacturer, wholesale distributor, or repackager using GS1 Standards for the Drug Supply Chain Security Act (DSCSA)? Learn how GS1 Standards can be applied for DSCSA serialization, lot-level management, and item-level traceability.

GS1 Standards for DSCSA Supplier

The DSCSA can be viewed as a three-phase implementation over 10 years. Phase 1 involves supply chain participants sharing lot-level, chain-of-ownership data starting in 2015. Phase 2 involves item-level identification and marking starting in 2017. And Phase 3 involves the electronic exchange of chain-of-ownership data to support serialized item traceability back to the product origin starting in 2023.*

On November 27, 2017, pharmaceutical manufacturers faced an important deadline: compliance with Phase 2 of the 2013 DSCSA. Although the U.S. FDA recently issued guidance indicating that it will delay enforcement of those requirements until November 2018, the implementation deadline remains in effect.**

GS1 US is pleased to offer a self-paced, on-demand training course designed to help you understand how to implement GS1 Standards for DSCSA requirements which will:

  • Help your organization prepare for DSCSA requirements
  • Effectively implement DSCSA lot-level management
  • Understand serialization and item-level traceability requirements

Need more info? 

*For information about the act, see the 2013 Drug Supply Chain Security Act  

**For information on the delay enforcement see the FDA Draft Guidance: Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy. June 30, 2017 

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 U.S. FDA.

Please note: orders are usually processed hourly between 8am – 6pm ET. Once processed, you will receive a system generated email and the purchased course(s) will be assigned to your learning plan (usually within an hour). If you purchase outside these hours, the course(s) will be processed at 9pm, midnight or at 5am ET respectively. If you do not see your purchased course(s) in your learning plan within 24 hours of purchase, please contact training@gs1us.org.  You will have unlimited access to the course for one year from the time of purchase.

GS1 Standards for DSCSA Suppliers Online Certificate Course includes six modules that allow you to apply GS1 Standards to prepare for DSCSA requirements.

  • GS1® Overview
  • GS1 Healthcare US®
  • Overview DSCSA Regulations and Timeline
  • Identifying DSCSA Information on Products
  • Capturing Information for DSCSA Purpose
  • Track and Trace Information Along the Supply Chain

Who Should Attend:

  • This certificate training is designed for pharmaceutical manufacturers, wholesale distributors, and repackagers using GS1 Standards for the Drug Supply Chain Security Act.

What You'll Learn: 

  • DSCSA overview and key milestones
  • The GS1 System of Standards and how it relates to DSCSA
  • How to obtain a GS1 Company Prefix that incorporates your NDC Labeler Code
  • How to use Global Trade Item Numbers (GTINs) to identify your lowest sellable units and homogeneous cases
  • Which GS1 Data Carriers can be used for DSCSA
  • How to use GS1 Application Identifiers for DSCSA product identification and marking
  • How to use Electronic Product Code Information Services (EPCIS) for DSCSA data exchange
  • Best practices provided in the GS1 US Implementation Guideline: Applying GS1 Standards for DSCSA and Traceability for managing in a mixed environment, exception processing, and forward and reverse logistics events

Earn a Badge - your GS1 Standards credential

Did you know when you successfully complete a GS1 US certificate course, you can earn an important credential in the use of GS1 Standards? And you can add this new skill to your online profile with a GS1 US Badge and share it via social media. Certificate badge for this course is valid for three years from the time of issuance. Learn more about our badging program.

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$495.00
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$495.00