This webinar is the first in a series that explores insights and approaches to attaining drug supply integrity while addressing the challenges of multi-tier, opaque supply networks and Drug Supply Chain Security Act (DSCSA) regulatory compliance.
For biopharmaceutical companies with complex supply chains, the manufacture, packaging, and distribution of drugs is often outsourced and not within direct management control. Companies are nevertheless responsible for ensuring the availability, quality, and regulatory compliance of their products. DSCSA requires unique item identification and comprehensive electronic transaction record histories. Supply chain Information management platforms typically lack the ability to serialize product, track and trace event histories, and provide transparency and early warning visibility of adverse events, but companies should be aware of emerging solutions that can support both DSCSA as well as overall standards-based supply chain visibility, planning and management.
Topics to be addressed include:
- Supply network dynamics unique to biopharmaceutical companies.
- DSCSA requirements and implications for information systems.
- Evolving SC architecture models for product information exchange and integration.
- Opportunities for value chain visibility, planning, and management in “right-sized” solution architectures.
Jim Baxter – Life Sciences Practice Leader, Collaborative
Gary Lerner – Founder, BrandSure, LLC
John Sharood – Chief Operating Officer, Vecco International Strategy