In a recent inspection, FDA issued an observation that should unsettle any manufacturer relying on […]
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Experienced professionals with manufacturing, quality assurance and regulatory affairs expertise in pharmaceuticals and medical devices.
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Dina Kisver has operating experience as Vice President of Quality for a manufacturer of active pharmaceutical ingredients. She holds an MS degree in Quality Assurance and Regulatory Affairs from Temple University.
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In a recent FDA inspection, investigators noted that airflow visualization studies used to qualify the […]
In our most recent GMP Trends Report Issue #1176, simple labeling gaps revealed deeper weaknesses […]