美国fd教材a验证高级培训.pptVIP

美国FDA验证高级培训 Denis Kluba 博士 吴培栋 博士 目录Table Of Contents 验证定义 CGMP对验证的要求 验证历史与期望 验证综述 验证主方案与规划 实施验证的方法 验证的技术内容要求 执行验证方案 工作流程 改变控制 再验证 总结 Part One: What is Validation? What is Validation? For this Seminar it refers to two things: 1. The USA FDA requirements that must be met in order to successfully and continually sell drug products in the USA 2. Activities that will contribute to the success of the company in the manufacture of drug products Validation Validation Is..... Why Do We Validate? To Consistently Produce A Desired Known Product How Do We Validate? Details Will Follow But