ICH Q9 Revision 1: Updates to Enhance Quality Risk Management in the Pharmaceutical Industry and a Pathway to a Robust Contamination Control Strategy
Originally issued in 2005, ICH Q9 laid down principles and examples of tools for QRM that can be applied throughout the product lifecycle. It was...
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Achieving Operational Goals with CAI
In today's rapidly changing market, companies must be agile and adaptable to meet fluctuating demands. Achieving operational goals amidst these changes requires flexibility in production...
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Leveraging CAI Human Performance Services for the “People in Plant” Program: Driving Excellence in Pharmaceutical Manufacturing
The "People in Plant" (PiP) program is pivotal in recognizing and enhancing the contributions of employees in a pharmaceutical manufacturing facility. Implementing such a comprehensive...
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Earned Value Management – Use It or Lose It!
Assessing project performance is both an art and a science. A successful methodology in evaluating project health and performance is Earned Value Management (EVM). This...
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Unlocking the Future: Exploring Cutting-Edge Cell and Gene Therapies
Unlocking the Future: Exploring Cutting-Edge Cell and Gene Therapies The world of medicine is in the middle of a transformative evolution following the advent of...
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The Initiation Stage of Technology Transfer
In the complex landscape of pharmaceutical and biopharmaceutical product development, the initiation stage of technology transfer (TT) is critical for ensuring successful scale-up and manufacturing....
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The Planning Stage of Technology Transfer
The Planning stage of technology transfer (TT) is crucial for ensuring a seamless transition of processes, resources, and knowledge from the Sending Unit (SU) to...
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CAI and Fedegari Group Forge Strategic Partnership to Deliver Transformational Turnkey Sterilization Solutions to Pharmaceutical Manufacturers
CAI’s best-in-class verification and risk management practices combined with Fedegari’s innovative sterilization equipment and engineering to reduce cost and accelerate speed to market INDIANAPOLIS (May...
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Exploring Sources of Communication Errors in Project Teams
Efficient communication stands as a cornerstone of thriving project teams, enabling the smooth exchange of thoughts, ideas, and emotions among members. Nevertheless, communication mishaps can...
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The Execution Stage of Technology Transfer
An Overview of the Execution Stage The Execution stage is the heartbeat of pharmaceutical technology transfer, where the meticulous planning of the Readiness stage comes...
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