Serialization deadlines in the U.S. and European Union have finally passed. Now what? As serialization mandates become increasingly complex, and aggregation becomes fully applied in the United States in 2023, pharmaceutical companies are scrutinizing whether their current serialization software is the best long-term solution.
Until now, most regulations―including the Drug Supply Chain Security Act (DSCSA)―have required minimal system capabilities. In the coming months, serialization systems will be tested for their ability to handle aggregation data, facilitate integration with distribution (internal and third-party logistics providers), integrate with downstream customers and handle complicated regulatory reporting requirements, such as the European Union’s Falsified Medicines Directive (EU FMD) and the Russian Federal Law No. 425-FZ.
Many players in the pharmaceutical industry have been feeling the pain of serialization solutions that are falling short. With the largest packaging-line installation base of any vendor, OPTEL often hears about these struggles: over-promised and under-delivered capabilities; high rates of issues and bugs; and the unexpected need to pay for costly “optional” tools and third-party resources to maintain a validated, high-performing solution.
If you are a pharma manufacturer and/or CMO and would like to better understand your serialization options for global requirements, join us for this 60-minute webinar September 11, 2019, 9 a.m.-10 a.m. EDT, as we share OPTEL’s approach to system conversions. We’ll discuss our tested methodology and real-life case studies, as well as the immediate and longer-term benefits of moving to the OPTEL serialization platform.
Julien Bigaouette, Solution Architect & IT Technical Lead in Serialization, OPTEL
Holding a master’s degree in IT management, Julien joined OPTEL in 2016 as a solution architect and IT technical lead in serialization projects at an international level. As a Subject Matter Expert for serialization solutions, his work consists in helping pharmaceuticals and manufacturing companies achieve their business objectives by leading enterprise software and serialization projects. He has worked with different partners along the supply chain and brings expertise from L2/L3/L4 & L5 to put in place solid IT solutions and act as a subject matter expert.
Bill Romano, Sales and Account Executive, OPTEL
Bill has spent the past two decades in the software-based platform and service industry working with enterprise, mid-sized and start-up companies. He has spent more than 10 years helping companies optimize their supply chain and operational efficiencies, and the past five years selling track-and-trace solutions to many industries around the world, including pharmaceutical, medical devices, and food and beverage. Bill is part of the OPTEL team that globally positions the Verify Platform, OPTEL’s L4/L5 solution.
Who Should Attend?
This webinar will appeal to professionals from hospitals, retail pharmacies and other organizations that are required to comply with EU FMD, including the following positions:
- Director of Pharmacy / Chief Pharmacist / Head of Pharmacy
- IT Manager / Director of IT
- Compliance Manager / Director of Healthcare Compliance / Hospital Compliance Officer
What You Will Learn
Participants will explore:
- Overview of global serialization requirements
- Overview and applications of end-to-end digital traceability
- Real-life case studies
- Long- and short-term benefits of switching providers
Founded in 1989, OPTEL is now a multinational, leading global provider of traceability systems practicing responsible human capitalism. The company’s mission is to use its innovative technologies to help create a better world. Namely, its renowned solutions ensure the quality of consumer health products and help stop counterfeiting of pharmaceuticals and medical devices throughout the world. In addition, OPTEL is adapting its technologies to create efficiencies in various other sectors ─ from health-related industries to smart manufacturing and more, all can benefit from global traceability. Through advanced characterization and cutting-edge algorithms ─ now all connected through the Internet of Things ─ OPTEL’s expert traceability solutions will allow diverse industries to measure, inspect, control and track a wide range of elements to improve product quality and make better use of resources. Based in Canada with additional facilities in the U.S., Ireland, India, and Brazil, as well as employees worldwide, OPTEL has expanded significantly in the past few years in order to meet growing industry needs and to support its humanitarian values. OPTEL is also a Certified B Corporation.