Reducing Human Error in GMP Operations: Building an Error-resistant Workplace from the Ground Up
In the pharmaceutical and biotech industries, delays in getting products to market cost companies revenue and inhibit patient access to their medications. CAI clients often...
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Technology Transfer Project Management Best Practices in the Era of COVID-19
Technology transfer is essential to advancing pharmaceutical products from development, through clinical and into commercial operation. The complexity of transferring the production of a product...
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Project Management “Impossibilities” – Running the Project Management Marathon
Running a race is easy, right? You get up early on a Saturday morning, lace up your sneakers, get in line and go. You eventually...
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QRM and the System Classification “Big Reshuffle”: Don’t Miss the Forest for the Trees
Recently, under its new Insights offering, KenX published an article, The Big Reshuffle – Impact Assessments and System Criticality, discussing the implications regarding the change...
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Understanding Failure to Ensure Proactive Maintenance
In today’s highly competitive environment, eliminating unplanned downtime is more important than ever, especially when that downtime occurs during a batch that places the product...
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You Can’t Distance From Quality
As an essential business, which must continue functioning in the current global environment, Pharmaceutical Manufacturing companies face unique challenges. Pharmaceutical Manufacturing relies on operating in...
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Is CSA Really a Game Changer for the Life Science Industry?
Computer Software Assurance (CSA) for Manufacturing, Operations, and Quality System Software Guidance – Is it the solution to arduous validations that the life science industry...
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