What Commercial Companies Need to Know about S&OP
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
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 [...]
Supply Chain Planning for Today’s Uncertain World
Webinar on October 19 @ 11a-12p Eastern Supply Chain Planning for Today's Uncertain World 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 managing the complexity of [...]
Building a Roadmap for the CMC Portion of Your BLA Submission
Webinar on June 20 @ 2-3:30p Eastern Building a Roadmap for the CMC Portion of Your BLA Submission The New England chapter of the PDA is offering this webinar where Todd Applebaum of Converge Consulting and Vijay Chhajlani of ModeX Therapeutics will break down the elements of a strong [...]
Bridging the Gap between Finance, CMC & Program Management in Emerging Biopharma Companies
Bridging the Gap between Finance, CMC & Program Management in Emerging Biopharma Companies The CMC landscape is complex, uncertain, and dynamic, driving the CMC team to constantly adjust their plans and timelines. It can be challenging for Finance to assess the upstream and downstream impacts of such changes. Similarly, strategic business changes [...]
What CMC and Finance Leaders Need to Know about Aligning CMC Programs with Finance
Webinar on May 26 @ 11a-12p ET What CMC and Finance Leaders Need to Know about Aligning CMC Programs with Finance CMC and Finance leaders often find themselves at odds with one another at many emerging companies. The CMC landscape is dynamic, often changing substantially. It can be difficult [...]
Transitioning to Computer Software Assurance from Computer Systems Validation
Transitioning to Computer Software Assurance from Computer Systems Validation Life science companies need to verify that GxP computer and software systems accurately support their intended business processes. The traditional approach for meeting this requirement is computer system validation (CSV). CSV emerged decades ago when computer systems were less reliable, and software was [...]
Event Recap: Building High-Touch Patient Supply Chains
Event Recap: Building High-Touch Patient Supply Chains Patient Outcomes: A Shift in Industry Focus The healthcare industry is increasing use of patient outcomes as a measure of quality and value. This drives biopharmaceutical companies to focus on patients in their commercial operations, technical operations, and supply chain. It was first prioritized [...]
Advanced Planning: Developing Supply Risk Mitigation Strategies
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 [...]