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, 21 [...]
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Inhalable Insulin: The Future Is Now
Guest content from Michael Shulman, editor of ChangeWave Biotech Investor:
The annual confab of the American Diabetes Association is underway and a question on the minds of many is “Will inhalable insulin succeed?” Billions of dollars have been put into research and clinical trials, one product Exubera from Nektar (NKTR) and Pfizer (PFE) has been approved [...]
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 [...]
