Hitoshi Matsushita
QA/QC, CMC research (Formulation, Analytical method, manufacturing)
QMS(Quality Management System), GMP(Good Manufacturing Practice), GDP(Good Distribution Practice), PQS(Product Quality System), Inspection from FDA and PMDA
change control, deviation control, CAPA, complaint handling, validation including CSV, self-inspection, vendor management, document control, data integrity, regulatory regulation, inspection from authority, audit vendor, CMO/CRO management
品質マネジメントシステム, GMP(JGMP, PIC/S GMP, cGMP, EU GMP), GDP(Good Distribution Practice), 品質管理システム, 査察対応(FDA, PMDA)