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The fact that good manufacturing practice (GMP) audits in the pharmaceutical and biotechnology industries have to be evaluated, and with very limited resources,
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Both internal and external GMP audits/inspections are a key requirement of Quality Management systems across medical device, biotechnology and pharmaceutical in
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The life sciences industry is changing rapidly and the historical rules, regulations, government oversight are under pressure to modernize. The recent introduct
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One of the most common reasons so many new drug, medical device, or equipment applications are rejected each year by the FDA is the failure to properly develop