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Jun 16, 2020 The U.S. Food and Drug Administration (FDA) revoked the emergency use authorization (EUA) that allowed for chloroquine phosphate and hydroxychloroquine sulfate donated to the Strategic National Stockpile to be used to treat certain hospitalized patients with COVID-19…
Quality can be defined as ‘Fitness for Purpose’, i.e.- the products or service should have the right features which satisfies the customers and are thus free from failures (no complaints, no rework etc.). The product should be consistent regarding its…
May 21, 2020 Regulators from around the world have agreed three priority areas for cooperation on observational research during COVID-19. They will collaborate on pregnancy research, on medicines used in clinical practice and on vaccine safety and effectiveness monitoring.…
“Higher quality is less expensive to product than lower quality”- W. Edwards Deming Quality comes with a cost. Often we have found companies struggling to strike a fine balance with the quality and cost. Quality managers sometimes struggles to…
As per ICH Q9 “Quality Risk Management is a systematic process for the assessment, control, communication and review of risks to the quality of the product throughout its life cycle.” There are many methods and tools to perform Quality Risk…