Judith S. Samardelis
GlaxoSmithKline
Senior Director, Head of CSQA Global QA
Judy Samardelis has been in the industry for over 20 years in various roles including:<ul>
<li>QC analyst in a GMP laboratory</li>
<li>Preclinical Study Director for Research and GLP studies</li>
<li>Drug Delivery and Formulation</li>
<li>Assay Development and Validation specializing in computer and laboratory validation using GAMP methodology</li>
<li>Sr Manager, QA Validation, Business Systems, Labs, Automation and Change Control</li></ul>
<br>
She received the Roger Sherwood Article of the Year at the ISPE 2009 Annual meeting for her article entitled Applied Quality Risk Management: Case Study – Laboratory Systems.
<br><br>
She is a contributing author of the revised GAMP Laboratory Good Practice Guide, Oct. 2012, a GAMP America’s Steering Committee member and member of the GAMP Cloud Sig.
<br><br>
She developed a process for the Qualification and continuous management and verification of Amazon Web Services’ IaaS platform.
<br><br>
She is a graduate from the University of New Hampshire, and is completing the MS Program in Biotechnology and Regulatory Science at the Johns Hopkins University, Baltimore.
<br><br>
She is the Director of IT Quality for AstraZeneca, based in Gaithersburg, Maryland.
<li>QC analyst in a GMP laboratory</li>
<li>Preclinical Study Director for Research and GLP studies</li>
<li>Drug Delivery and Formulation</li>
<li>Assay Development and Validation specializing in computer and laboratory validation using GAMP methodology</li>
<li>Sr Manager, QA Validation, Business Systems, Labs, Automation and Change Control</li></ul>
<br>
She received the Roger Sherwood Article of the Year at the ISPE 2009 Annual meeting for her article entitled Applied Quality Risk Management: Case Study – Laboratory Systems.
<br><br>
She is a contributing author of the revised GAMP Laboratory Good Practice Guide, Oct. 2012, a GAMP America’s Steering Committee member and member of the GAMP Cloud Sig.
<br><br>
She developed a process for the Qualification and continuous management and verification of Amazon Web Services’ IaaS platform.
<br><br>
She is a graduate from the University of New Hampshire, and is completing the MS Program in Biotechnology and Regulatory Science at the Johns Hopkins University, Baltimore.
<br><br>
She is the Director of IT Quality for AstraZeneca, based in Gaithersburg, Maryland.