Quality
July 3, 2026Most quality teams understand what a CAPA is supposed to accomplish. They know the process: identify the problem, investigate the…
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June 12, 2025Bringing a new company to life in a highly regulated industry isn’t for the faint of heart. At CH House…
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May 15, 2025The Digital revolution is reshaping how companies approach quality. From cloud-based QMS platforms to AI-powered data analytics, organizations are leveraging…
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March 13, 2025In highly regulated sectors like food, pharmaceutical, medical device, manufacturing, & life sciences, a robust quality culture isn't just a…
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January 30, 2025Last year, the FDA issued over 2,500 483 observations across life sciences industries. Each citation represented not just compliance failures,…
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January 15, 2025We often hear about "Lean" as a magic bullet for efficiency and cost reduction. But what happens when Lean principles…
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August 12, 2024In the fast-paced world of innovation, bringing a new pharmaceutical & medical device to market is an exhilarating journey. However,…
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July 25, 2024I recently read a post from USA Today about a listeria outbreak linked to deli meat that left two dead…
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June 25, 2024Let's face it, receiving an FDA 483 Warning Letter can be a stressful experience & a challenging moment for any…
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June 25, 2024Many associate quality with the final product inspection – the eagle-eyed team catching defects before they reach the customer. While…
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March 1, 2024As we navigate the evolving terrain of Quality Management Systems (QMS), three key trends stand out, reshaping our approach to…
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March 1, 2024With over two decades in the Regulatory and Quality Assurance field, particularly in the Life Sciences industry, I’ve seen firsthand…
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