郑金旺,上海东富龙科技股份有限公司副总经理、技术总监
国家药品食品监督管理局高级研修学院特聘专家,ISPE中国生产及工程委员会委员、会员发展委员会主席,中国医药设备工程协会专家,中国制药装备行业协会专家委员会专家。16年无菌冻干行业经验,曾经多次到欧、美、日制药生产企业及制药设备制造企业进行技术交流,在无菌冻干注射剂和无菌原料药核心区域生产线工艺设计、风险控制、冻干系统设计、冻干设备验证、项目管理等方面具有丰富的经验。作为讲师,多次参与国家药监总局认证中心、国家药监总局高研院、各省药监局认证中心或安监处、各行业协会等组织举办的技术交流和培训。
Zheng Jinwang, Technical Director of Shanghai Tofflon Science and Technology Co., Ltd, visiting professor of State Food and Drug Administration Institute of Executive Development, expert of Pharmaceutical Association of Plant Engineering, expert of Expert Committee under China Association for Pharmaceutical Equipment, ISPE’s member; with fifteen years of experience in sterile freeze-drying industry, he engaged in technical exchange to European, US and Japanese pharmaceutical manufacturers and pharmaceutical equipment manufacturers for many times and has gathered rich experience in production line process design, risk control, freeze-drying system design, freeze-drying equipment validation, project management of cores areas for sterile freeze-drying injection and sterile active pharmaceutical ingredients etc. As an lecturer, he participated in technical exchange and training organized by Certification Center of State Food and Drug Administration, State Food and Drug Administration Institute of Executive Development, certification centers or safety supervision sections of food and drug administrations at provincial level, industry associations etc for many times.