This certificate training is designed for pharmaceutical manufacturers, wholesale distributors, and repackagers using GS1 Standards for the Drug Supply Chain Security Act (DSCSA). 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.
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.
While Phase 1 focused on the exchange of lot-level chain-of-ownership data among all supply chain partners, Phase 2 focuses on item-level serialization. Pharmaceutical products must be marked with a National Drug Code (NDC), Serial Number, Lot Number, and Expiration Date in both machine-readable and human-readable format.**
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.
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
Featured Special Guest:
Scott Mooney, VP Distribution Operations, McKesson
Who Should Attend:
Pharmaceutical manufacturers, wholesale distributors, repackagers, solution providers, and 3rd party logistics providers with responsibility for DSCSA implementation in their organizations.
Need more info?
Not sure if this certificate course is for you?
Attend our free 20-minute preview webinar (Note: you will need to create a free account to view) for a preview of the full-day
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 resume with a GS1 US Badge and share it via social media. Learn more about our badging program.
* Source: FDA Draft Guidance: Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy. June 30, 2017.
** Source: 2013 Drug Supply Chain Security Act.
Disclaimer: GS1 US is not a representative or agent of the FDA, and the content herein has not been reviewed, approved or authorized by the FDA.
Location
GS1 US, Chicago Office
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Suite 1400
Chicago, IL, 60606
Chicago area hotels with GS1 US negotiated rates. Please contact hotel directly to book preferred rate.
Due to the overwhelming hotel demand and high occupancy rates, hotel rooms and GS1 US preferred rates are always subject to availability.
Crowne Plaza Metro Downtown
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Holiday Inn Express Magnificent Mile
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The Godfrey Hotel Chicago
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Wyndham Grand Chicago Riverfront
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