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.**
This one-day course will help you prepare for DSCSA by learning about how GS1 Standards can be applied for DSCSA serialization, lot-level management, and item-level traceability. The course is intended to educate you on implementing business processes to help support supply chain in meeting the DSCSA by using GS1 Standards to track and trace products at the product and case level. This course will introduce and explain key practices used to promote DSCSA, product-level traceability, and provide guidance about how these best practices can be implemented by your company, and trading partners.
Featured Special Guest: Scott Mooney, VP Distribution Operations, McKesson
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*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**For information on the delay enforcement see the FDA Draft Guidance: Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy.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.
Who Should Attend:
Pharmaceutical manufacturers, wholesale distributors, repackagers, solution providers, and 3rd party logistics providers with responsibility for DSCSA implementation in their organizations.
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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