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GxP Processes and Risk Assessment - ICH Q9 Quality Risk Management
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GxP Processes and Risk Assessment - ICH Q9 Quality Risk Management
GxP Processes and Risk Assessment - ICH Q9 Quality Risk Management
GxP Processes and Risk Assessment - ICH Q9 Quality Risk Management
GxP Processes and Risk Assessment - ICH Q9 Quality Risk Management
GxP Processes and Risk Assessment - ICH Q9 Quality Risk Management
GxP Processes and Risk Assessment - ICH Q9 Quality Risk Management
GxP Processes and Risk Assessment - ICH Q9 Quality Risk Management
GxP Processes and Risk Assessment - ICH Q9 Quality Risk Management
GxP Processes and Risk Assessment - ICH Q9 Quality Risk Management
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  Post Number #1  
Old 18th January 2011, 01:46 PM
v9991

 
 
Total Posts: 952
Question GxP Processes and Risk Assessment - ICH Q9 Quality Risk Management

Are there any GxP relevant processes which can be assessed low on risk?
'Risk'' i mean by the ''ímpact'' part of the risk described in ICH Q9.
risk = severity/impact[S] x occurrence[O] x detection/control[D].

My perception is that, overall risk (SxOxD) could be definitely evaluated to be 'LOW" but all GxP relevant process can't be always assessed low on impact!

thanks in advance for your thoughts.

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  Post Number #2  
Old 20th January 2011, 08:02 AM
Stijloor's Avatar
Stijloor

 
 
Total Posts: 15,335
Re: GxP Processes and Risk Assessment - ICH Q9 Quality Risk Management

Quote:
In Reply to Parent Post by v9991 View Post

Are there any GxP relevant processes which can be assessed low on risk?
'Risk'' i mean by the ''ímpact'' part of the risk described in ICH Q9.
risk = severity/impact[S] x occurrence[O] x detection/control[D].

My perception is that, overall risk (SxOxD) could be definitely evaluated to be 'LOW" but all GxP relevant process can't be always assessed low on impact!

thanks in advance for your thoughts.
Can someone help?

Thank you!!

Stijloor.
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