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This course is designed to provide sound training on how to recognize and address atypical or out of specification results, using approaches which have been recommended by regulatory authorities, and how to perform investigations to assure both compliance and good business decisions. The course stresses timely, consistent investigations focused on identifying the root cause and taking appropriate actions regarding the disposition of the data and the material, as well as corrective or preventive actions to avoid similar situations in the future. There will be an exercise using a participant's example to work through an investigation, as well as ample opportunity for questions and discussion.
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