Converge Supply Chain Series webinar on 6/18/20
New Challenges in Serialization & DSCSA
Now that federal DSCSA serialization regulations are being enforced for U.S. manufacturers, focus is shifting from first-time implementation to the challenges in serialization execution, management and delivery of business value. Forward-thinking companies are developing strategies for analyzing serialized data to identify efficiencies and improve outcomes.
Even companies that are implementing serialization for the first time are finding the experience very different than it would have been just a few years ago. New entrants and offerings make the solution landscape more confusing. In addition, ongoing support and administration reaches broadly across the organization and can be more than expected.
Join Supply Chain, Manufacturing, QA, IT, Finance, and CMC peers to discuss these new challenges along with ways to increase the value of your serialization efforts and data. This will include tips addressing compliance, management and maintenance, along with using data to gain competitive advantage.
Challenges Up for Discussion
- Aligning requirements with actual solution capabilities
- Solution validation for virtual manufacturers
- Global market expansion
- Management & governance in a lean supply chain environment
- Unique obstacles confronting emerging companies
- Performing analytics using data mining & data extraction
- Data integration & workflow
- Using data to improve on-time deliveries & recall management
- Master data management
- Labeling design
- Packaging operations validation
Webinar Event Details
Date: Thursday, June 18, 2020 @ 12pm EDT – 1pm EDT
Agenda:
12:00pm - Opening
12:10pm – Panelist Remarks
12:30pm - Q&A with Discussion
Speakers
Gary Abernathy
Director of Supply Chain Management at Karyopharm Therapeutics
Gary Abernathy is an innovative supply chain leader with over 20 years of experience at Karyopharm, Aegerion, Inspiration and EMD Serono. In 2 years at Karyopharm, Gary built the commercial supply chain organization in preparation for the successful commercial launch of Selinexor. He is now laying the foundation for upcoming label, market and portfolio expansion. Previously, Gary developed, implemented, and ran planning & inventory management at Aegerion and Inspiration. He also led supply chain due diligence and integration efforts for Aegerion’s acquisition of Myalept, along with supply chain preparation for EMD Serono’s successful launch of Egrifta. Gary has selected, integrated, and managed multiple contract manufacturing, labeling, and global third party logistics providers for Aegerion, Inspiration, and EMD Serono.
Todd Applebaum
Managing Director at Converge Consulting LLC
Todd Applebaum has supported many clients transitioning from clinical development to commercial production of Biologics, Pharmaceuticals, and Cell Therapies. He consults on business strategy, manufacturing, technical operations, the quality system, process development, operational strategy & execution, supply chain management, business process/workflow automation and IT enterprise solutions. Prior to starting Converge Consulting, Todd served as VP, Technical Operations at Ovascience, Inc., helping transition the company from research to commercial operations. He also held the role of VP, Research for the Healthcare and Life Science industries at Gartner, Inc. where his research focused on building patient outcomes-focused operations, the impact of personalized and precision medicines, global operations and network planning, track & trace technologies and operational & performance excellence. Todd has a BS in Industrial Engineering from General Motors Institute and an MBA from Carnegie Mellon University.
Stephanie Byrne
Serialization & Project Management Senior Consultant, Converge Consulting
Stephanie Byrne is a Serialization expert and Supply Chain Project Manager. She helps clients bridge the gap between sound strategy and reliable tactics by increasing the impact of process, technical, and configuration choices. Stephanie has more than 25 years of integration experience and a focus on implementing serialization for pharmaceutical track and trace. She helped nearly a dozen life sciences companies implement serialization for DSCSA and EUFMD compliance across brand owners, CPOs, 3PLs and serialization solutions.
Prior to Converge, she led new software implementation, B2B integration and enhancement projects from business case development through post go-live support with Maxiom Consulting Group and Coopers & Lybrand. Stephanie has managed multiple phases of ERP software implementations across order-to-cash, procure-to-pay, manufacturing, distribution, procurement, and inventory management. In roles with Momentive Specialty Chemicals and Waters Corporation, she managed integration projects across the sales, procurement, supply chain and finance functions, while also leading an eBusiness/B2B integration program linking electronic catalogs, purchase orders and invoices to exchange eProcurement systems transactions. Stephanie earned her MBA and BS in Management from Rensselaer Polytechnic Institute. She is a certified TraceLink Administrator and has obtained Smartsheet certification, PMI certification, and GS1 standards certification for DSCSA.