Human 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,...
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Pioneering 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...
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Driving 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...
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Engaging 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...
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Empowering 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...
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Sustaining 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...
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A 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...
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Innovative 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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Addressing the Biotech Workforce Shortage: CAI’s Role in Strengthening Industry Talent
In today’s biotech and pharmaceutical industries, a critical challenge persists: the shortage of a skilled workforce. For innovation in biotechnology to thrive, there must be...
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Insights Within Life Sciences in 2025
The year 2024 has witnessed significant changes in the life sciences industry, characterized by seismic shifts in international regulations, a resurgence of national quality and...
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