Tag Archive: quality assurance

Jul 28 2011

Imaginary patients, Imaginary data, et Cetero, et Cetero…

The FDA recently issued a letter to a CRO based in Cary, NC, outlining serious violations at one of their facilities including “widespread falsification of dates and times in laboratory records… and the apparent manipulation of equilibration samples to meet predetermined acceptance criteria.”  This letter is a follow-up to two on-site audits, conducted as a …

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Mar 12 2010

Cato at the SQA 26th Annual Meeting and Quality College

The Society of Quality Assurance (SQA) will be holding its 26th Annual Meeting and Quality College on 25-30 April 2010 in Cincinnati, OH.  Three days of plenary and concurrent sessions will explore hot topics and the latest regulatory interpretations in the field.   Sessions will focus on regulatory-based topics in manufacturing (GMPs), preclinical (GLPs) and clinical …

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