Building the Future of Pharmaceutical Manufacturing: A Phased Approach to Dark Factories
Why Invest in a Dark Factory? Pharmaceutical manufacturers are under increasing pressure to meet growing patient demand, accelerate drug development timelines, and adapt to evolving...
Read MoreHuman Factors in Pharma Manufacturing: Beyond Error Prevention
Introduction: Why Human Error is a Failing Root Cause Pharmaceutical manufacturing operates in highly regulated, high-stakes environments where deviations can impact product quality, patient safety,...
Read MorePioneering Progress: How Innovation is Transforming Manufacturing Operations
Manufacturing has entered a new era in which success depends on more than traditional optimization methods. While Lean and Six Sigma have served as foundational...
Read MoreDriving Operational Excellence: Leveraging Technology for Industry-Wide Innovation
Introduction: The Next Evolution of Operational Excellence Operational Excellence (OE) has long been the foundation of high-performing industries, ensuring efficiency, reliability, and quality in Life...
Read MoreEngaging Early: FDA’s Collaborative Pathways for AI in Regulatory Applications (Part 3 of 3)
Nick Armstrong, Senior Director of Digital Enablement at CAI and co-chair of the ISPE Community of Practice on AI, specializes in the intersection of artificial...
Read MoreEmpowering Operational Readiness: How Advanced Technologies Reshape Industry Practices
Operational readiness is a critical milestone for any organization embarking on new projects or processes. Achieving readiness requires more than just meticulous planning; it demands...
Read MoreSustaining Reliability: Life Cycle Maintenance of AI Models in Drug Development (Part 2 of 3)
Nick Armstrong, Senior Director of Digital Enablement at CAI and co-chair of the ISPE Community of Practice on AI, specializes in the intersection of artificial...
Read MoreA Framework for Trust: Understanding the FDA’s AI Risk-Based Credibility Assessment (Part 1 of 3)
Nick Armstrong, Senior Director of Digital Enablement at CAI and co-chair of the ISPE Community of Practice on AI, specializes in the intersection of artificial...
Read MoreInnovative Approaches to Quality and Engineering Management: Transforming Life Sciences Manufacturing
The path to operational excellence is continually being redefined. Today’s manufacturers face mounting pressure to enhance product quality, improve compliance, and optimize operational efficiency—all while...
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