本次培训侧重实战，以稽查计划、执行、报告和跟进为基础，课堂以讲师讲解策略——学员实战——讲师点评思路进行技能提升，让学员切实掌握具有高级稽查的临床研究设计策略。
第一天
08:45-09:00 Registration/注册
09:00-09:10 Welcome and Course Objectives/欢迎词及课程目标
09:10-10:00 What Is ‘Audit’ and Its purpose/何为“稽查“及其目的
The concepts of quality assurance, quality control, quality management and audit are discussed./质量 保证、质量控制、质量管理体系和稽查
10:00-11:00 Workshop 1: Getting prepared for an Investigator Site Audit (ISA)/研讨会1:准备研究中心 稽查
Techniques for the selection and planning an ISA, as well as in-house data review in order to conduct an effective ISA./研究中心稽查选点和计划技巧，以及内部数据审核方法，以确保稽查的高效执行
11:00-12:00 Workshop 1: Review and Feedback/研讨会1:回顾和反馈
12:00-13:00 Lunch/午餐
13:00-14:00 Live Audit Role Play: Opening Meeting and Interview/稽查角色扮演：稽查开场会议和面谈
Auditor and auditee behaviors are explored and strategies developed for successful audit interaction
稽查员和被稽查方的行为解读，以及如何达成成功的稽查互动
14:00-14:30 nterview Techniques/面谈技巧
Getting Pertinent Information via Interview/如何通过面谈获取切题的信息
14:30-15:30 Computerized System Validation and 21 CFR Part 11/计算机系统验证以及21 CFR Part 11
Expectations of different computerized systems and their validations/不同计算机系统的期待及其验证要求
15:30-18:00 Special Considerations when Auditing a GCLP Laboratory/稽查GCLP实验室需要特别考虑 的方面
Review of a standard QMS within GCLP, external and internal QA and QC program, equipment and facility, reagent management. /审核GCLP下标准的质量管理体系、内部和外部QA 和QC程序、设备实施和 试剂管理
第二天
09:00-11:00 Special Considerations when Auditing a CRO/稽查CRO时的特别考量
Explore techniques when performing a qualification audit and a periodic assessment. /执行CRO资格审 核稽查和定期稽查的技巧
11:00-12:00 Live Audit Role Play: Closing Meeting/稽查角色扮演：总结会议
Reviewing and categorizing your observations and getting ready to present your case./回顾并将发现分 类，并准备向被稽查方陈述你的发现。
12:00-13:00 Lunch/午餐
13:00-14:00 Deal with Tough Situations/处理复杂情况
Share tough situations, e.g. time constraints, culture shock, fraud, with the trainee and explore solutions./通听众探讨各类复杂情形，例如时间显示、文化冲突、造假等，并探索处理方案。
14:00-16:00 Workshop 2 Audit Report Writing/研讨会2: 稽查报告写作
The content and distribution of an effective audit report are investigated and the importance of effective written communication is discussed./高效稽查报告的内容和分发、以及如何高效通过书面方式 进行沟通
16:00-17:00 CAPA and Follow-up/CAPA和跟进
The auditor’s role in monitoring responses to audit and the corrective and preventive actions promised is explored./稽查员在监控稽查回复以及CAPA执行中的角色和方法。
17:00-17:30 Panel Session/讨论
An opportunity to get answers to outstanding questions./答疑
17:30-17:45 培训结束，颁发结业证书
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