ARTICLES BY JERRY CHAPMAN
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How Do FDA, MHRA, & Russia's Drug Inspectorate Evaluate & Escalate Inspection Findings?10/21/2020
Representatives from the Russian Federation State Institute of Drugs and Good Practices, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA), and the U.S. FDA share their processes for evaluating and escalating inspection findings to determine if regulatory action is needed.
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Comparing The Top 10 Pharma Inspection Findings From FDA, MHRA, & Russia's Drug Inspectorate10/7/2020
Representatives from the Russian Federation Ministry of Health, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA), and the U.S. FDA share their top 10 pharma company inspection findings from FY2019, revealing many similarities and a few differences.
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Life Science Chief Quality Officers Are Redesigning Quality For The 21st Century3/27/2019
With input from FDA and regulators, CQOs are pursuing means to analyze huge data sets, manage complex manufacturing systems, and operate smoothly between varied products, languages, and cultures.