cGMP北大培训教材.pdf

Centre for Pharmaceutical Information and Engineering Research Peking University, Beijing, CHINA, 100871 Tel: 86-10-6275-6142; Fax: 86-10-6275-8023 2008 级国际药物工程管理硕士课程讲义 3-2 2007 级国际药物工程管理硕士课程讲义 12-2 cGMP Field Inspection cGMP 现场检查 Robert C. Horan, Ph.D. Pharmaceutical Inspectorate, Food and Drug Administration, USA 美国 FDA 药品检查员 Master Degree Program of International Pharmaceutical Engineering Management 国际药物工程管理硕士项目 Centre for Pharmaceutical Information and Engineering Research, Peking University 北京大学药物信息与工程研究中心 2008年 5月 26-27 日 Robert Horan 博士 Robert C. Horan, PhD. Dr. Horan has been employed by FDA as a field investigator for 15 years and is one of the members of FDAs newly formed Pharmaceutical Inspectorate. This group is composed of the most experienced field investigators throughout the United States. He has conducted inspections of pharmaceutical companies in the US, Europe, China, India, Japan and other countries in Asia. Dr. Horan received his PhD in Physiology from St. Johns University, New York, USA and prior to coming to FDA taught full time at the university. Received M.S. in Microbiology and worked for several years as a full time Microbiologist before beginning the doctoral program. Robert Horan 已在美国FDA 作为现场检查员工作了十五年，并是新近成立的“FDA 药品检 查处”成员。该处聚集了全美最富经验的 cGMP 现场检查员。Horan