Judith S. Samardelis

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>
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.
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.
She developed a process for the Qualification and continuous management and verification of Amazon Web Services’ IaaS platform.
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.
She is the Director of IT Quality for AstraZeneca, based in Gaithersburg, Maryland.