202511PDA CCS的根本原因分析_(中英文)

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pda.org
©PDA 2025
pda.org
©PDA 2025
PDA From Findings to Fixes: Strengthening CCS in Aseptic Manufacturing
Workshop 2025
Root Cause Analysis of
a CCS
David Keen
个人数字助理
©PDA 2025
PDA从发现到修复:加强无菌生产中的中国化学会
2025年研讨会
大卫·
CCS的根本原因分析
pda.org
©PDA 2025
Introduction
When is a contamination failure a CCS failure?
CCS is a continuous feedback loop that tells you about the health of your manufacturing system
Your CCS should have metrics for control/not in control for each Critical Control Point (CCP)
You should know what your CCPs are
What happens when something goes wrong and your CCS says everything is OK?
Have you missed a control point in the CCS?
Has the CCS failed?

标签: #中英文 #PDA #CCS

摘要:

pda.org©PDA2025pda.org©PDA2025PDAFromFindingstoFixes:StrengtheningCCSinAsepticManufacturingWorkshop2025RootCauseAnalysisofaCCSDavidKeen个人数字助理©PDA2025PDA从发现到修复:加强无菌生产中的中国化学会2025年研讨会大卫·基CCS的根本原因分析恩pda.org©PDA2025IntroductionWhenisacontaminationfailureaCCSfailure?CCSisacontinuousfeedbackloopthattellsyo...

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作者: 51zlzl 分类:专业资料 价格:60质量币 属性:84 页 大小:539.75KB 格式:PDF 时间:2025-11-21
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