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 [...]
PDF Available > Focusing on patients and improved outcomes in a rapidly evolving environment requires maintaining appropriate controls to ensure quality and compliance from early in the lifecycle. A well-designed and stage-appropriate Quality Management System (QMS) is essential to facilitate the development and commercialization of these advanced treatments. Converge Consulting understands the complexities and [...]
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 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 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 [...]
Life Sciences Supply Chain Working Group Webinar January 20, 2022 @ 12-1p ET The Drug Supply Chain Security Act (DSCSA) requires pharmaceutical trading partners to share data that tracks products and provides traceability through the supply chain. The sharing of data is dependent on the Electronic Product [...]
Benefits of Using Foreign Trade Zones for Emerging Biotech Companies We often see clients incurring high duties on importing key starting materials into the US. For emerging companies conducting R&D, paying duty on each import can significantly impact cashflow, sometimes measuring in the hundreds of thousands of dollars. This impact is amplified [...]
Helping the Biotech Industry Bring Crucial Healthcare Innovations to Market Todd Applebaum recently talked with Mission Matters about helping the biotech industry bring crucial healthcare innovations to market. Read the interview highlights on the Mission Matters website. Watch the full interview here:
Pushing “Fast Forward” on Serialization Requirements: What Manufacturers Need to Do for 2022 Originally published as a MassBio Guest Blog Stephanie L Byrne is a senior supply chain consultant and serialization lead focusing on DSCSA project leadership. She has helped more than a dozen life sciences companies realize the greatest impact from [...]
2022 Industry Serialization Requirements: Assessing 3PL Options for Sending EPCIS Data to Distributors Pharmaceutical manufacturers currently share transaction data with their trading partners at the lot level. The Drug Supply Chain Security Act (DSCSA) mandates package level traceability by November 2023. Cardinal Health and McKesson are requiring that manufacturers provide fully aggregated [...]