Archive for 2007

Offshoring and U.S. Biotech Labor Shortages

   July 23, 2007    Comments Off on Offshoring and U.S. Biotech Labor Shortages    Posted in: General Biotechnology, Guest content

Guest content contributed by Agnes Shanley, Editor in Chief, Pharmaceutical Manufacturing Every day we read about severe shortages of skilled biotech workers in the U.S.. At the same time, the trend to pharma offshoring and outsourcing is becoming more pronounced, and is moving from traditional pharma to biopharma. We recently touched on some of these […]

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

   July 19, 2007    Comments Off on `Til Death Do Us Part, But First, the Pre-Nup: Why CAPA Needs to Evolve    Posted in: General Biotechnology, Guest content

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, […]

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