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...
Read MoreExploring 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...
Read MoreThe Execution Stage of Technology Transfer
The Execution stage is the heartbeat of pharmaceutical technology transfer, where the meticulous planning of the Readiness stage comes to fruition. This critical phase involves...
Read MoreAnnex 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...
Read MoreTranslating Study Reports – A GLP Draft Guidance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,...
Read MoreFDA’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...
Read MorePatient Safety is the Perspective for Prevention
When I first started writing this blog, the subject was remediation for regulatory inspections. But, as I progressed through the authoring of this blog, I...
Read MoreSupply Chain Resilience
Most people take for granted that medication prescriptions will be ready at the pharmacy counter and available for pick up when ordered to get themselves...
Read MorePatients emerge as the ultimate beneficiaries of Aseptic Processing Technology advancements
Aseptic Processing Technology advancement innovations such as robotics, artificial intelligence, & rapid test methods have continued to ensure the production of safer, more effective medical...
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