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What Should Really Trigger a CAPA?

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Corrective and preventive action (CAPA) is often a thorn in the side of medical device manufacturers.

Is the FDA Creating a HACCP Program for Produce?

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Although the announcement, “FDA Proposes Changes to Food Safety Modernization Act Rule to Enhance Safety of Agricultural Water Used on Produce,” is a bit to fully digest in one sitting, I’m intrigued by the FDA’s focus on pre-harvest risk assessment of water risk as

Boosting Vaccine Production Needs the Right Degree of Flexibility

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The pandemic has seen an unprecedented global effort to accelerate the development of safe and effective vaccines as well as a rapid expansion of vaccine manufacturing capacity.

Reporting All Biosafety Errors Could Improve Labs Worldwide

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The origin of SARS-CoV-2 remains a mystery.

What Is Blockchain 2.0, and Why Should Food Manufacturers Care?

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Believe it or not, the technology that brought you Bitcoin is beginning to make waves in the food manufacturing industry. This technology, called blockchain, is a digital ledger maintained across several computers, then linked through a peer-to-peer network.

FDA Compliance

FDA Compliance

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Operational Readiness: The Precursor to Operational Excellence

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Following any tech transfer project, the subsequent startup of the manufacturing line is almost always full of challenges.

Inspection and Compliance in One Reliable Package

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In regulated industries, every step of the production process must be verified to some sort of guidance or standard. What this comes down to, practically speaking, is an enormous amount of time and effort spent on actions outside the sphere of production.

The FDA’s Weak Drug Manufacturing Oversight Is a Potentially Deadly Problem

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How Food Processors Can Improve FDA Compliance and Productivity at the Same Time

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To meet increasingly strict compliance standards, such as the Food Safety Modernization Act (FSMA) and Global Food Safety Initiative (GFSI), food processors now regularly use adenosine triphosphate (ATP) testing to monitor equipment surfaces for microbial growth.

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