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