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The U.S. Food and Drug Administration (FDA) conducts inspections of pharmaceutical companies to ensure compliance with regulatory requirements and good manufacturing practices (GMP). One outcome of these inspections is the issuance of an FDA Form 483, which outlines observations of potential violations of GMP. In this video, we will provide tips and strategies to reduce the number of FDA 483 observations and improve compliance with regulatory requirements. We will also discuss the importance of implementing corrective and preventive actions (CAPA) and the role of effective communication in reducing FDA 483 observations.
Details: https://www.pharmaguideline.com/2016/...
#FDA483observations #compliance #quality #pharmaceuticals #GMP #CAPA #communication #science
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