Nattina R. Vichkulwrapan, M.A., M.S.J. is a Quality-focused leader with 20+ years of industry experience driving impactful policy initiatives to increase efficiency and reduce costs within the Pharmaceutical and Medical Device industries. She has experience implementing, auditing and maintaining Quality Management Systems as well as deploying the corresponding GXP compliant electronic systems. Nattina has specifically led and executed a robust Quality Plan for the transition of systems, data, accessibility, and supporting documentation from existing company to another. Her responsibilities have included ensuring all development programs and deliverables meet patient/customer requirements, and comply with standards and regulatory requirements, including but not limited to GCP, GLP, cGMP, applicable ISO standards 13485, 14971, 17025, and 14155, ICH guidelines, and national laws including FDA, EU Directives, Health Canada, PIC/S, and PMDA, and spearhead efforts toward continuous improvements that are aggressively pursued on an ongoing and proactive basis. Nattina provides oversight and direction for QA compliance, executes audit plans and ensures robust CAPA resolution for programs and systems. Supervised dedicated quality auditors and international consultants, and provided GCP QA oversight and leadership during the conduct of multiple Phase I-III, pivotal device and feasability trials, successful PAI readiness, and agency, site, and sponsor inspections obtaining FDA product approval. Nattina holds a Bachelor of Science in Chemistry from Rensselaer Polytechnic Institute, Troy, NY, a Master of Arts in Biology from Lehman CollegeCity University of New York, Bronx, NY, and a Master of Science in Jurisprudence & Health Law Policy degree from Seton Hall University Law School, Newark, NJ.