WHEN: Wednesday, September 11, 2019 from 9 am-10 am EDT
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 State 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 from 9 am-10 am 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, Software Solution Designer
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
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, med device and food and beverage. Bill is a part of the OPTEL team that globally positions OPTEL’s L4 / L5 solution, the Verify Platform.