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Pratiksha Parekh, MS, MS, is a highly experienced professional in the pharmaceutical and biopharmaceutical industries, currently serving as a Principal Consultant at CAI since July 2008. In this role, Pratiksha leads Technical Quality groups focusing on Quality Risk Management, Deviation, and Change Management systems, while also providing quality support for facilities, utilities, maintenance, engineering, and validation. Prior to this position, Pratiksha worked as a Validation Engineer and has extensive experience in handling commercial drug substances and products at major pharmaceutical companies. Previously, at Regeneron Pharmaceuticals, Pratiksha was a Process Scientist, transitioning from a Manufacturing Associate to Downstream Process Scientist, with responsibilities related to monoclonal antibodies. Pratiksha holds a Master of Science in Regulatory Science from The Johns Hopkins University, a Master of Science in Chemical Engineering from Columbia University, a Bachelor of Arts in Economics, and a Bachelor of Science in Biochemical Engineering from Rutgers University.