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Sung Nyeo Shim


Sung Nyeo Shim

Chong Kun Dang Pharmaceuticals, SOuth Korea

Biography

Sung Nyeo Shim has approximately 18 years of experience in the field of QA, QC, COMPLIANCE of BIOLOGICS; QMS; GMP TRAINING & BIOLOGICS ANALYTICAL TEST METHODS TECH TRANSFER; FILING SUPPORT with REGULATORY AFFAIRS. She is enthusiastic, energetic, organized, multifunctional individual with integrity, highly self-motivated. She has Delivered milestones in a timely manner with teams, evaluated CMO/CRO, PAI readiness, interacted with Regulatory authorities. She has QC lab qualification, analytical method development, qualification, and validation per ICH guidelines. She has also Monitored biologics manufacturing, data integrity/analysis/troubleshooting/OOS/RCA investigation.

 

Abstract

Abstract : Biosimilars Analytical Strategies