FSMA 204 Compliance: lessons learned from the Drug Supply Chain Security Act (DSCSA) and the Partnership for DSCSA Governance (PDG)
Learn how the PDG has helped the drug supply chain to not only comply but has essentially re-written the playbook on collaboration and information sharing and provides demonstrable evidence as to the power of public/private partnerships.
Picture this: Divergent industry groups working on disparate plans for compliance lacking a coordinated timeline and plan for how to meet compliance date; a clear need for more collaborative interactions with FDA, absent a single, consistent set of business requirements to which commercial solution/software providers could build. Sound familiar? These are some of the challenges that the Pharmaceutical industry faced when the Drug Supply Chain Security Act was passed in 2013. Today, the Partnership for DSCSA Governance has filled these voids, addressed the challenges & is a testament to the power of the collaborative mindset. In this informative session, learn how the PDG has helped the drug supply chain to not only comply, but has essentially re-written the playbook on collaboration and information sharing and provides demonstrable evidence as to the power of public/private partnerships.
Presented by: Eric Marshall, J.D. is a principal with Leavitt Partners and the Executive Director of the Partnership for DSCSA Governance (PDG), a public-private partnership between industry and FDA that is committed to implementing supply chain security protections in the U.S. A seasoned facilitator and consensus-builder, Eric leads Leavitt Partners’ robust alliance practice.
Jason Bashura will open the session and introduce Eric Marshall