过程确认及方法概述讲解.pptVIP

Process Validation Approach Overview过程确认及方法概述 Agenda/Topics日程 / 主题 What is Process Validation? 什么是过程确认？ Brief history of validation 确认的简要历史 Who concerns about validation? 谁关心确认？ Expectations 期望 Definitions/Compliance 定义 / 符合性 Validation Economics 确认的经济意义 Examples of Warning Letters 警告信的案例 Elements of Process Validation 过程确认的要素 When to Validate 何时确认 Validation Master Plans 确认主计划 What is Required to Be Outstanding in Process Validation? 确认中需要强调什么？ Steps to Validation of a Process 过程确认的步骤 Proto