Whether you’re getting your first FDA approval, choosing a CPO or tackling the global market, compliance requirements impact every company—regardless of your business model.

You know you need to serialize to comply with government mandates such as DSCSA or EU FMD. But the journey from initially Googling “traceability” to achieving full serialization compliance is complex.
Let us guide you through the challenges and outcomes with two pharmaceutical companies who have successfully navigated the path to compliance for their different businesses.

Join Joe Lipari, Director - Global Traceability from Systech, as we map out a proven route to serialization success along with Steve Kane, Head of Product Integrity Program Global IT for Shire and Ann Schaefer, Director - Supply Chain Management at Acorda Therapeutics.

The panel will discuss:
• Complexity of the regulations
• Hurdles they overcame
• Solutions that carried them over the finish line

Featured Speakers

Joe Lipari

Director, Global Traceability
Systech International

Joe Lipari is the Director of Global Traceability for Systech International and product manager for the UniTrace cloud based traceability and serialization solution. Joe is skilled at communicating complex technical topics to c-level as well as technical listeners. Joe has served in roles spanning engineering and management of global teams in the serialization and supply chain areas.  Most currently, in the Director role, is responsible for the go to market strategy and product roadmap for the UniTrace product.

Steve Kane

Head of Product Integrity Program Global IT
Shire

Steve currently directs all Global IT initiatives in support of serialization and product integrity at Shire.  Significant responsibilities include: regulatory assessments, program management, requirements definition, business case development, supply chain integration, trading partner communication, anti-counterfeit technology evaluation, engineering integration, packaging line support, EPCIS system administration, budget control and reporting, staff management and evaluations. 

Ann Schaefer

Director, Supply Chain Management
Acorda Therapeutics

As Director, Ann is responsible for the Commercial Supply Chain working with Acorda’s Manufacturing site, Contract Manufacturers, Packagers and Third Party Logistics partners. In addition, Ann is Program Lead for the Drug Supply Chain Security Act (DSCSA) Implementation Team. She has been with Acorda for ten years and has over 25 years of experience working in production and inventory management, operations management and quality assurance for FDA regulated companies.

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