Automated process management systems are the workhorses of every modern company. These systems guide operations and improve quality and efficiency. Hidden away in the core of each automated [...]
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In Warning Letters/Recalls, Medical Device Industry, FDA Regulated Industries, Quality Management, Regulatory Compliance ManagementPosted
Three recent warning letters from the Center for Device and Radiological Health (CDRH) offer a glimpse into ongoing medical device inspection investigative focus. CAPA non-compliance is a top [...]
In FDA Regulated, FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance ManagementPosted
After a bit of a lull, the U.S. Food and Drug Administration (FDA) issued a batch of warning letters focused on pharmaceutical manufacturing quality issues in the first quarter of 2017. Examples [...]
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