July 22, 2024 || Harry Benson
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 you to have thought of everything that requires funding without excessive capital or operational budget overrun. Based on your experience at a previous facility, you…
July 11, 2024 || Jeff Hall
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 planning and inventory management. CAI is here to help you develop streamlined processes that minimize downtime and maximize productivity, enabling a more efficient and responsive…
July 11, 2024 || Jeff Hall
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 initiative requires specialized expertise, strategic planning, and a nuanced understanding of both human resources and the pharmaceutical industry. This is where consultants play a crucial…
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…
October 12, 2017 ||
A tale of why read and acknowledge is a failed method of operator training.
