Why Industry-Wide Standards Matter In Fulfilling the Intent of DSCSA

• Christiane Wirrig, PhD | Customer Success Manager, Spherity
• David Kessler | Co-owner and President, Legisym

Discussion on the importance of standardization in order to digitalize the U.S. pharmaceutical supply chain as motivated by the Drug Supply Chain Security Act (DSCSA).

Key topics

• What is DSCSA?
• What does FDA’s Stabilization Period mean?
• Why do technology standards matter and how are they being implemented, i.e. interoperability through standards?
• Focus on standardization, due diligence in the context of DSCSA-regulated digitally managed pharma supply chain
• 2023 readiness in relation to stabilization period until 2024
• Inspections will keep happening
• ATP is mandatory, authentication & authorization
• Data security