GS1 Connect 2021 Digital Edition: Move Beyond Supply Chain Challenges
Date: June 8-10, 2021 (Register by June 3, 2021)
Session 701: An Automated Approach to Drug Traceability Readiness
Speaker: Gary Lerner President Gateway Checker Corporation
Conference Track: Tech
This presentation will examine enhanced drug distribution security requirements and what it means for industry participants from an information exchange perspective. In short, the enhanced drug distribution security aspect of DSCSA mandates the exchange of a transaction record it each change of ownership.
By 2023, U.S. pharmaceutical manufacturers will need to send serialized data, along with shipped product, to meet DSCSA traceability requirements. However, assessing drug traceability readiness can be inexact, time-consuming, and resource intensive. To achieve accurate, rapid, robust, and reliable connectivity with minimal errors, conformance to accepted standards is essential and can identify gaps in preparedness and inform compliance planning. Join this session to hear about an automated solution that can evaluate pharmaceutical manufacturers’ readiness.
- What information must be captured and exchange?
- What standards exist to support this?
- What are the challenges?
- How can an automated approach more effectively assure drug traceability readiness?
Gary Lerner, founder of Gateway Checker, is an accomplished architect of supply integrity solutions. An expert in item-level serialization, Gary has developed successful supply chain and channel integrity solutions for nearly 100 leading brands around the world, serving the needs of pharmaceutical, medical device, packaged food, electronics and apparel manufacturers. Over the past 18 years, he has worked with more than 60 leading brands, serving the needs of pharmaceutical, medical device, packaged food, electronics, consumer, and apparel manufacturers. He has been actively involved in facilitating FDA regulatory compliance and enabling supply network interoperability. Gary is an active participant in medical device and pharmaceutical GS1 industry initiatives, starting in 2010. A member of the GS1 Healthcare industry workgroup, Gary helped to craft the Implementation Guidelines for Applying GS1 Standards for DSCSA and Traceability, published in 2016.
More about GS1 Connect 2021: Move Beyond Supply Chain Challenges
Join innovators and business leaders at this year’s supply chain conference as they identify breakthrough possibilities for the future.
Gain insights from industry peers, innovators, and industry leaders on:
- Meeting shifting consumer demands with complete and accurate data
- Driving engaging customer experience through unique identification
- Enabling end-to-end supply chain visibility using GS1 Standards
- Connecting digital and physical supply chains through technology
- How to drive supply chain innovation, agility, and resilience in a COVID-19 world