NDAA高级稽查实战培训—Advanced Auditing: Audit Planning, Conduct, Report and Follow-up

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

-会议门票-