由德国弗戈工业媒体主办的“2015弗戈制药工程国际论坛”于6月4日在江苏泰州举行。论坛汇集PROCESS《流程工业》杂志全球(德文版、英文版、印度版)力量，采用主会场与分论坛相结合，力求营造重点突出、主题明确的专业学术氛围。以下是制药行业专家何明先生在2015弗戈制药工程国际论坛上关于“药厂偏差管理的研究”的发言。

演讲现场

关于何明先生：

从美国留学归来的何明先生，有着在医药工业界工作20多年的实践经验，过去的5年中将欧美制药、生物药、医疗器械领域的最新的质量管理的理念引进到了中国。他在美国曾为莫沙东，先灵宝雅，安进等跨国制药企业提供GxP的咨询服务。他是质量保证，确认/验证，分析实验室，计算机/IT等领域的专家。他精通于FDA/EMEA/ICH规范，并熟练地将其应用于原料药，口服制剂，无菌工艺等产品的开发和生产中。他曾为雅培，药明康德等公司长期以顾问身份担当质量负责人。他成立的咨询公司已为辉瑞，礼来，雅培，诺华等成功完成多项质量相关的项目，他还为国外客户提供第三方审计，并帮助中小公司建立并提高质量管理系统。他公司提供过服务的爱美津，普克等公司都顺利地完成了FDA的审查。

Mr. He has 20 years of pharmaceutical, biotech, and medical device industry experience, in past five years he has returned to China with the most updated western quality management methodology. He had previously provided GxP compliance services to clients in US such as Merck, Schelling-Plough, and Amgen. His expertise areas cover quality assurance, qualification/validation, analytical laboratory, and computer/IT. He is familiar with FDA/EMEA/ICH regulations and guidances, and applying them to relative areas of API, drug products, and/or sterile product development and manufacturing. He acted as quality leader for Abbott, WuXi AppTec for extended periods as consultant. The company he established has successfully completed multiple quality related projects for clients like Pfizer, Lilly, Abbott, and Novartis. He provided third party auditing services for clients outside of China, facilitated inexperienced local Chinese companies to establish or improve quality systems, provided training services to educate clients staff for GMP compliance. The companies that his firm had provided extensive services, such as Amerigen, PuraCap has successfully passed FDA inspection.