Converge Perspective on the FDA Delayed Enforcement Originally published on the MassBio News & Thought Leadership blog On June 2, 2023, the Healthcare Distribution Alliance (HDA) submitted to the Federal Drug Administration (FDA) a letter outlining challenges for implementing the last mile of DSCSA compliance. Chief among these is manufacturers’ inability to [...]
ERP Implementations: Understanding Technical Versus Business Go-Live Many life science companies rely on enterprise resource planning (ERP) to help manage and integrate essential parts of the business. Implementing an ERP solution is a major undertaking for any organization. Even when the right ERP option is selected, implementation must consider the needs of [...]
DSCSA Implementation & Readiness Efforts for 2023 2023 is a crucial year for pharmaceutical trading partners as the Drug Supply Chain Security Act (DSCSA) deadline for full traceability approaches in November. To allow supply chain stakeholders an opportunity to share their perspectives, the FDA held a 2-day virtual public meeting. DSCSA Implementation [...]
Minimizing COI & COC Risk 3 Essential Components for Autologous Cell Therapy Facilities Originally Published as a MassBio Guest Blog Autologous cell therapies involve collecting and processing a patient’s own cells, and later administering the processed cells back into the body to treat the same patient. The personalized nature of these [...]
What Commercial Companies Need to Know about S&OP Sales and Operations Planning (S&OP) is an iterative planning process. It ensures cross-functional alignment on sales forecast and performance, as well as manufacturing forecast and performance. It also provides visibility into forecasted demand and an accurate view of volumes for inventory and production. With [...]
Event Recap: 2022 & Beyond - Serialization Requirements for Manufacturers To ensure product safety, the Drug Supply Chain Security Act (DSCSA) requires pharmaceutical trading partners to share data that tracks product movement and traceability through the supply chain. The sharing of data is dependent on the Electronic Product Code Information System (EPCIS). Although [...]
Webinar on October 19 @ 11a-12p Eastern Supply Chain Planning for Today's Uncertain World Read the Event Recap Supply chain leaders in life sciences companies operate in a highly uncertain environment. Commercial and regulatory uncertainty is now compounded by the risk of supply disruptions and geopolitical barriers. For companies [...]
Advanced Planning: Developing Supply Risk Mitigation Strategies Download the PDF Converge conducts a Manufacturing Supplier Risk Assessment and uses the results to build a Supplier Risk Management Plan. A commercial biopharmaceutical company was preparing for their second product launch when senior leadership acknowledged the need to prioritize the supply chain and manufacturing [...]
Are You Ready for Serialization Implementation? A 7-Point Checklist for Emerging Pharma Companies Serialization implementation is probably on your radar already if you’re an executive at an emerging Biopharma company. Manufacturers need to implement a serialization management solution to fulfill today’s requirements under the Drug Supply Chain Security Act (DSCSA). So [...]
