Early Bird Fee (expires July 21, 2017): $695.00 per person
Regular Fee (after July 21, 2017): $895.00 per person
Fee: $895.00 per person
This one day certificate course is designed for manufacturers, wholesale distributors, and healthcare providers, as you prepare for the requirements of DSCSA. Phase 2 of DSCSA is just less than a year away in November 2017, which requires 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. The use of GS1 Identifiers, Application Identifiers, and Data Carriers barcodes are covered in this workshop. In the GS1 System, the GS1 Global Trade Item Number® (GTIN®) is used to represent the NDC.
Although the DSCSA law specifies 2023 as the year when serialized item traceability is required, many trading partners have already made significant investments in serializing product lines and implementing serialized item traceability systems. And as more and more trading partners start to transition from lot-level management to serialized item traceability, it is reasonable to expect that the U.S. pharmaceutical industry will experience a mixed environment of lot-based and serialized item information throughout the 2016 - 2023 time frame. We will review aspects of the Implementation Guideline which provides the basics on how to identify and mark products, as well as how to share change-of-ownership information at the lot-level, as well as the serialized item-level. You will learn information on how to manage in a mixed environment, and provide specific guidance on exception processing, and addition forward and reverse logistics events.
What you'll learn:
What the FDA’s Drug Supply Chain Security Act (DSCSA) is and what milestones are included
What the GS1 System is and how it relates to DSCSA
How you can use your Labeler Code as part of a GS1 Company Prefix
How to use Global Trade Item Numbers® (GTINs®) to identify your Lowest Sellable Units and Homogenous Cases
What GS1 Data Carriers can be used to comply with DSCSA
How to capture the required production Information in your barcodes using Application Identifiers
How Electronic Product Code Information Services (EPCIS) is used related to DSCSA
If you have any questions, please contact email@example.com.
Princeton Pike Corporate Center
1009 Lenox Drive, Suite 202
Lawrenceville, NJ 08648
Lawrenceville area hotels with GS1 US negotiated rates
Springhill Suites Ewing Marriott
Rate 126.00 USD
Courtyard Marriott Princeton
Rate 149.00 USD
Due to the overwhelming hotel demand and high occupancy rates, hotel rooms and GS1 US preferred rates are always subject to availability.