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

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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Insights Within Life Sciences in 2025
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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
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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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Equipment Is Ready, But Are Your Operators? The Case for Prioritizing Training
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Equipment Is Ready, But Are Your Operators? The Case for Prioritizing Training

In the pharmaceutical manufacturing world, regular collaboration between teams is critical for success; for example, project managers, department managers, quality assurance leads, engineers, and sterility...

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The Future of AI-Driven Operational Readiness – An Outcome-Based Approach to Enhanced Process Validation and Asset Performance
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The Future of AI-Driven Operational Readiness – An Outcome-Based Approach to Enhanced Process Validation and Asset Performance

As AI and related technologies continue to advance, the potential to reshape operational readiness grows exponentially. The future of AI for use in operational readiness...

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The Near Future of AI in Operational Readiness – Automating Tedious Tasks to Augment Daily Execution
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The Near Future of AI in Operational Readiness – Automating Tedious Tasks to Augment Daily Execution

Through slow but sure incorporation, AI is now supporting operational readiness efforts  by automating and augmenting the routine, repetitive tasks that often slow down daily...

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CAI Unveils Bold New Brand Identity at ISPE Annual Meeting & Expo
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CAI Unveils Bold New Brand Identity at ISPE Annual Meeting & Expo

Orlando, FL – [October 14, 2024] – CAI, a trailblazer in operational readiness and excellence, is thrilled to announce a comprehensive rebranding initiative, set to launch...

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CAI Appoints Sheena Dempsey as Chief Executive Officer
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CAI Appoints Sheena Dempsey as Chief Executive Officer

Indianapolis (October 2, 2024)—CAI, a global professional services firm and trailblazer in operational readiness and excellence, today announced Sheena Dempsey as Chief Executive Officer (CEO)....

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How Digital Twins are Optimizing Biotechnology Production and Changing the Workforce for the Future
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How Digital Twins are Optimizing Biotechnology Production and Changing the Workforce for the Future

The workforce is transforming rapidly, driven by technological advancements like Digital Twins. These virtual models replicate real-world systems in a digital space, and their integration...

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The Handover Stage of Technology Transfer: Ensuring a Seamless Transition for Commercial Production
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The Handover Stage of Technology Transfer: Ensuring a Seamless Transition for Commercial Production

Transitioning from technology transfer (TT) to routine commercial production poses significant challenges for biopharmaceutical companies. Ensuring a seamless handover from the TT Team to the...

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LESSONS LEARNED FROM IMPLEMENTING THE FDA’s CSA GUIDANCE: PART 3 –SUMMARIZING
Blog Post

LESSONS LEARNED FROM IMPLEMENTING THE FDA’s CSA GUIDANCE: PART 3 –SUMMARIZING

This is the last installment of a three-article series that presents several lessons learned by our validation team while completing a pair of validation projects...

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