Quali-Tea with Anne

Top FDA 483's and how to avoid them


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In this conversation, Anne, Kim, and Troy discuss the top FDA 483 observations of 2023. They cover the top observations for medical devices and pharmaceuticals, including issues with CAPA, complaint handling, supplier quality management, quality control and documentation, personnel training, and equipment and facility deficiencies. They emphasize the importance of effective procedures, training, and alignment between procedures and actual practices to address these observations. They also discuss the need for proactive measures and continuous improvement to prevent recurring issues.

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Quali-Tea with AnneBy Anne MacNeil