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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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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