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了解美国食品与药物管理局(FDA)对制药商的检查
了解美国食品与药物管理局(FDA)对制药商的检查
本课程讲述 FDA 对制药设施检查的基本知识,包括检查授权、目的、类别以及通常会检查的领域/运营。本课程还将讨论公司及其员工通常应如何应对 FDA 的检查以及如何与调查员进行有效的互动。本课程讨论的主题包括:范围、检查类别、启动、应对检查、检查范围、与 FDA 的互动和总结。完成本课程后,学员将能够了解 FDA 制药设施检查的基本知识、公司应如何应对 FDA 的检查以及如何与调查员进行有效的互动。
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Course Objectives:
Identify the basics of FDA inspections of drug manufacturing facilities, including authority, purpose, types, and the areas/operations typically inspected. Identify how firms should handle FDA inspections and interact effectively with Investigators.