Category: Guest content

`Til Death Do Us Part, But First, the Pre-Nup: Why CAPA Needs to Evolve

A guest editorial from Emil Ciurczak, Contributing Editor, PharmaManufacturing.com While reading a trade magazine recently, I was struck with the detailed information on how to design and implement a Corrective and Preventive Action (CAPA) system. ISO 9001:200, Clause 8.5.2 states, “…the organization shall take action to eliminate the cause of nonconformities encountered…” For medical devices, […]


Lessons and analogies from other industries

Guest content from John Avellanet, managing director of Cerulean Associates: As professionals affiliated with the biotechnology industry, we often forget that many of the struggles faced today have been solved before by other fields and industries. As Ambrose Bierce wrote, “There is nothing new under the sun, but there are lots of old things we […]