上传一份关于change control的资料

beiwei5du · 发表于 2015-12-25 23:00:40

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上传一份change control的资料，希望大家看完后多多交流！谢谢！

Table of Contents
About the Authors
Principles of Change Control..............................................................................................3
Introduction and Operation of Change Control Programs.....................................................................6
Parallel Programs.........................................................................................................7
Company-Wide Programs ....................................................................................................7
Grading the Changes ......................................................................................................8
Trials....................................................................................................................10
Deviations................................................................................................................10
Change Control Committee..................................................................................................10
Documentation.............................................................................................................12
Change Requests...........................................................................................................12
Appendices................................................................................................................21
A. CMS’ Change Control Management Plan Version 1.0
B. Change Management Plan Version 1.0
C. EMA Questions and Answers on Post Approval Change Management Protocols

Ben跑 · 发表于 2020-4-13 14:24:03

下来看看

ssm123 · 发表于 2020-4-15 11:41:34

学习学习，谢谢楼主

凡9731cacf · 发表于 2020-4-15 12:36:39

学习一下，谢谢分享

Mint · 发表于 2020-4-15 14:41:52

谢谢楼主分享

小金库 · 发表于 2022-9-22 21:06:30

非常感谢分享

[GMP相关] 上传一份关于change control的资料

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