[Histonet] Validation Sign off

[tapiarita]

“Based on FDA’s ruling on class reagents in IHC, the legal responsibility for validation and knowing the relevant parameters is put squarely on the shoulders of the lab director.” True, the legal responsibility rests with the lab director..


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-------- Original message --------
From: Laurie Colbert <lcolbert <@t> pathmdlabs.com> 
Date: 09/11/2013  10:45 AM  (GMT-07:00) 
To: "Histonet Post (histonet <@t> lists.utsouthwestern.edu)" <histonet <@t> lists.utsouthwestern.edu> 
Subject: [Histonet] Validation Sign off 
 
When validating IHC antibodies and detection kits (either initially or with new lots), does a pathologist have to sign off on the validation , or can it be his/her designee (such as a PhD) that signs off?  The pathologist will be signing the IHC procedures.

Laurie Colbert, HT (ASCP)

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