Process Validation Proposal Email, March 30, 2012 - Ducord
From: Gavin, Denise K
Sent: Friday, March 30, 2012 5:25 PM
To: 'Amanda Parrish, Ph.D.'
Subject: RE: For Review: Duke/CCBB Process Validation Proposal
I discussed the confirmatory HLA test with Mercy.
Her question to you is "Why do you do the confirmatory testing?"
She said you could drop it.
Please replace it with a prospective analysis of current data...i.e. how frequently has there been a discrepancy between initial and confirmatory HLA testing in HPC-Cs tested in 2011? were these investigated or how is the discrepancy handled?
Submit that data analysis along with your process validation report as supportive data.