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Pre-Approval Inspection PAI

 
 
» Reasons for conducting a PAI
  This section describes the various reasons for conducting a pre-approval inspection and the main U.S. and EU registration applications.  
» Pre-inspection activities
  This section will help you to understand why pre-inspection activities are crucial to successfully passing a pre-approval inspection.  
» During the inspection
 

This section shows how closely success or failure is linked to the skills and capabilities of the personnel an inspector encounters and the importance of optimum backroom organization.

 
» The exit meeting
  This section will give a brief description of a standard PAI exit meeting – usually held on the final day of the inspection – and offer some advice on appropriate attitudes and responses.  
» Post-inspection activities
 

This section provides guidance on how to respond to the inspector’s assessment, including proposed timescales and some further recommendations for post-inspection activities.

 


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