US FDA inspections, current good manufacturing practices and the new "healthcare fraud"
This article was originally published in SRA
Executive Summary
Ellen Leinfuss discusses six key triggers that may attract an inspector's aggressive scrutiny of cGMP compliance and product quality.
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Ellen Leinfuss describes the major warning signs that indicate a company may be heading towards quality problems and offers advice on how to address them.
Seven signs that your quality programme is in trouble
Ellen Leinfuss describes the major warning signs that indicate a company may be heading towards quality problems and offers advice on how to address them.
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