The Journal of Validation Technology
Vol. 23, Issue 6, Dec 2017

Melanie Demakis
,
Melissa Carella
A productive workforce depends on women. Our "Women in Validation" panel provided a collected voice for women to discuss key challenges in a male-dominated industry, with tactics every woman can use to empower herself.
Mark Balhorn
This paper introduces a sampling plan approach to Attribute Test Method Validation (ATMV) and shows its performance to be superior to the widely used kappa statistic.
Adonis Senra
,
Alberto Leyva
,
Gudelia Pérez
,
Iriac Bisquet
,
Manuel Montané
,
Rodolfo Valdés
,
Sonny Robles
,
Tania de la Cruz
Compressed air is widely used in the biotechnological industry. Impurities in compressed air may jeopardize intermediate and final products leading to quality deterioration. Qualification and validation of compressed air systems is mandatory to obtain a compressed gas with all quality attributes.
Tim Sandle
Microbial tests can be variable and there are several factors to be considered, which makes the microbial challenge approach worthy of separate review. The review is important, given the continued widespread practice of microbial liquid immersion challenge tests.
Willis H. Thomas
Dr Willis Thomas of Akorn Pharmaceuticals reviews his presentation entitled "Educate for Data Governance," originally presented live at two IVT Network global conference in 2015 and in 2016. D
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