Judy Samardelis has been in the industry more than 20 years in various roles of Quality Control, including Study Director of Preclinical Studies, Drug Delivery, Assay Development and Validation and several years specializing in Computer and Laboratory Validation using GAMP methodology in support of multi site implementations, utilizing a risk based streamlined validation approach to project implementations. Samardelis has recently begun working in the Medical Device Industry. In her current role, she supports the Research and Development organization from a Software QA perspective, as well as the continued role of Computer Systems validation in support of the Qiagen business processes. She is Chair of the Pharmaceutical Engineering Committee Editorial Review Board, Co-Chair of the GAMP Risk SIG team, a GAMP Steering Committee Member and member of the GAMP Laboratory GPG revision/authoring team. Judy has a B.A in Microbiology from the University of New Hampshire, Durham.