ispe2014speakers演讲人信息.pdfVIP

大会主持人/Chairmans 薛斌 中国食品药品国 中国食品药品国际交流中心副主任 Xue Bin 际交流中心 Deputy Director-General of China Center for Food and Drug International Exchange of CFDA China Center for Food and Drug International Exchange of CFDA 独立咨询顾问 顿昕 先生 Independent 独立咨询顾问，主要面对医药行业，从事 GMP审计，法规咨询等工作。 consultant and 目前是中国医药质量管理协会特聘专家，国家食品药品监督管理局高级研修学院客座教授，北京大学国际药物工程 GMP auditor for 管理 IPEM 硕士项目教师、论文导师。ISPE 中国法规委员会委员。 pharmaceutical 顿昕先生曾在默克公司担任法规技术顾问 3 年，-密理博公司担任验证经理 5 年。在此之前，他已经有 11年的无菌 industry 药品生产经验，历任 QA经理，生产部经理及总工程师等职。 顿昕 在国家食品药品监督管理局及省市药监局组织的无菌专题培训中多次担当主讲人，也是新版 GMP 指南-无菌药品分 Dun Xin 册-编写组成员。 Mr. Bill dun Bill is an independent consultant and GMP auditor for pharmaceutical industry. He is also expert of China Quality Association for Pharmaceuticals, Registered professor of SFDA (state food and drug administration) institute of Executive development, teaching faculty and thesis adviser of Peking University IPEM master’s degree program, member of ISPE regulatory committee in China. He used to be full time consultant for Merck for 3 years and validation manager of Millipore for 5 years. Before that, he had already worked for sterile product manufactures for 11 years as QA manager, production manager, and chief engineer. Bill has been invited to have lots of training for GMP inspectors and industry from 2009 on th