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Planning for a Talented Workforce: Building a Staffing Plan for New or Expanding GMP Facilities
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Planning for a Talented Workforce: Building a Staffing Plan for New or Expanding GMP Facilities

Let’s contrast two very real scenarios: You are responsible for bringing a new GMP facility or line to full-scale production. Your board or shareholders expect...

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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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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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CAI Accelerates Operational Readiness and Excellence across the Life Sciences and Mission-Critical Space for a Future of Precision, Innovation & Efficiency

Operational readiness and operational excellence are crucial to the life sciences and mission critical industries, as they are highly regulated and require stringent compliance standards....

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