课程安排

11月14日（周四）

Part1计算机化系统生命周期良好管理及实施

Good management and implementation practices throughout the lifecycle of computerized system

• 计算机化系统项目建设实施良好管理

Good management of construction and implementation of computerized system project

• 供应商管理、审计及注意事项

supplier management,audit and points to consider

• 计算机化系统管理文件架构

Management documents structure of computerized system

• 计算机化系统变更控制良好实施

Good practices of change control of computerized system

• 计算机化系统定期回顾或再验证的良好实施

Periodic review and re-validation implementation of Computerized system

• 计算机化系统电子记录电子签名的良好管理及实施

Good management and implementation of electronic records and electronic signatures in computerized systems

• 计算机化系统安全控制良好管理及实施

Good management and implementation of computerized system safety control

• 计算机化系统应急预案管理及良好实施

Computerized system emergency plan management and good implementation

• 计算机化系统校准和维护

calibration and maintenance of computerized system 

Part2  不同类别的计算机化系统搭建及验证实施要点

Different types of computerized system construction and key points of validation implementation

• 常见计算机化系统的分类实施

Classification of general computerized systems

• 计算机化系统基础架构的确认

Verification of computerized system infrastructure

• 计算机化系统应用程序的验证

validation of computerized system application

• ERP/MES/SCADA系统搭建技巧及验证实施要点

ERP/MES/SCADA system construction skills and validation implementation key points

• 计算机化系统网络安全验证及要点解析

Computer system network security verification and key points analysis

• 计算机化系统数据安全存储及备份恢复要点分析

key points Analysis of data security storage and backup recovery in computerized system

11月15日（周五）

Part1 基于GAMP5的良好计算机化系统验证实施

Good implementation of computerized system validation based on GAMP 5

• 药监机构对计算机化系统的理解及要求

Regulatory authority’s understanding and expectation of computerized system 

• 计算机化系统验证良好实施及注意事项

Good implementation and considerations of CSV

• 计算机化系统验证文件（GxP评估、URS、VP、RA、FDS、SCR、DIOP、TM、VSR等）实施技巧

Implementation tips of CSV documents(GxP assessment, URS, VP, RA, FDS, SCR, DIOP, TM, VSR etc.)

• 计算机化系统验证常见问题及解决方案

Common problems and solution program of CSV

Part2  基于GAMP5的遗留计算机化系统验证实施

Good implementation of legacy computerized system validation based on GAMP 5

• 遗留计算机化系统的特点

Characteristic of legacy computerized system

• 药监机构对遗留计算机化系统的理解及要求

Regulatory authority’s understanding and expectation of legacy computerized system

• 遗留计算机化系统的验证良好实施及注意事项

Good implementation and considerations of legacy computerized system

• 遗留计算机化系统验证文件（GAP、整改计划、验证方案、整改报告）实施技巧Implementation tips of legacy computerized system documents(GAP, correction plan, validation protocol and correction report)

• 遗留计算机化系统验证常见问题及解决方案

Common problems and solution program of legacy computerized system