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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Annex 21 – Are we on track and is there an impact?
Annex 21 went into effect on August 21, 2022. It’s time to check that processes and procedures have not fallen short of the actual requirements...
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Translating Study Reports – A GLP Draft Guidance
In a global community, studies are often conducted by testing facilities located outside of the United States of America, including countries such as Brazil, China,...
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FDA’s Advanced Manufacturing Technology Program: Accelerating the Drive to integrated Automated Manufacturing
The US Food and Drug Administration (FDA) has launched a new Advanced Manufacturing Technologies (AMT) Designation program aimed at accelerating the implementation of technologies that...
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