Blog
April 23, 2021 || Niall Killeen & Brian Nieport
Life has been turned upside down during the COVID-19 pandemic with travel restrictions, self-isolation/ quarantining requirements, and social distancing measures implemented to slow the spread of the virus. The world must go on, services and products must be delivered. But applying traditional methods will not be sufficient. Current restrictions do…
March 31, 2021 || Harry Benson
As most of our industry now recognizes, “Human Error” is not a root cause of issues and deviations. CAI has developed and used a Human Error Decision Tree to help with RCA and CAPA related to human error. The diagram below is an excerpt from this tool to show possible…
March 18, 2021 || Jeff Hall
In an industry where the need for accuracy and compliance is essential, there is a category of error which still occurs at an astounding rate, affecting both cost and product availability. In the case where the human is part of the process, there will always be a “human error” factor. …
March 3, 2021 || Harry Benson
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 seek help in closing open investigations, but ignore the source of these investigations, even while product sits quarantined. Where clients really need help is in…
December 30, 2020 || Charlie Maher
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 from a sending unit to the receiving unit is challenging even in the best of conditions. Since the onset of the COVID-19 pandemic the industry…
December 8, 2020 || Josh Hoops
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 get to the end and cross the finish line. Easy day. Now, let’s be realistic. Every runner, cyclist, swimmer, or other flavor of endurance athlete…
November 2, 2020 ||
Recently, under its new Insights offering, KenX published an article, The Big Reshuffle – Impact Assessments and System Criticality, discussing the implications regarding the change in approach from System Level Impact Assessment (SLIA) and Component Criticality Assessment (CCA) to System Classification (SC) and System Risk Assessment (SRA) in ISPE Baseline…
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July 30, 2020 ||
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 at risk. Did you know “best-in-class” maintenance organizations spend 90% of their total maintenance time on proactive maintenance (planned, kitted and scheduled corrective, preventive, and…
