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本帖最后由 蒲公英 于 2014-10-10 10:31 编辑
马义岭 Peter Ma
Vice general manager of Austar Group, manager of the GMP Compliance & Quality Management Consulting Services Department, a member of the Promotion Sub-committee of International Society for Pharmaceutical Engineering (ISPE), a professional lecturer for C&Q course and a senior consultant for validation and GMP compliance. 奥星集团副总经理，GMP合规性及质量管理咨询服务部经理，国际制药工程协会（ISPE）中国分会会员发展委员会委员、调试与确认（C&Q）课程专业讲师，资深验证与GMP合规性咨询顾问 Nearly 20 years practical experience in the pharmaceutical industry and over 10 years GMP consultancy and guidance experience, with in-depth study and unique insight on pharmaceutical related regulations and guidelines. Managing a team with more than 160 professional GMP consulting engineers specialized in validation, testing, engineering, quality system, and regulatory registration, etc. 拥有近二十年的制药行业实践经验和十余年的GMP咨询指导经验，对制药行业相关法规和指南有极其深入的研究和独到的见解。现管理包括验证、测试、工程、质量、注册等专业在内的专业GMP咨询工程师队伍达160余人 Since 2011, over 50 public lectures and trainings on various forums organized by many well-known pharmaceutical associations at home and abroad. Topics of lectures include but are not limited to “Commissioning and Qualification”, “Risk Management”, “Computerized System Validation”, “Establishment of Quality Management Systems, “Solutions for New GMP Certification”. 自2011年起，先后受邀在多家国内外知名制药行业协会所组织的各类论坛进行公益演讲和培训近五十余场。演讲议题包括但不限于“调试与确认”、“风险管理”、“计算机化系统验证”、“质量管理体系建设”、“新版GMP认证解决方案”等 Presided over editing and publishing of “Pharmaceutical Process Validation Manual”, took the lead to perfectly combine the advanced international ideas with pharmaceutical validation practices. Participated in the editing and publishing of “Microorganism Control in Pharmaceutical Clean Room” and “Pharmaceutical Fluid Process Implementation Manual” in 2013. Presided over the editing and publishing of Compilation of EU GMP/GDP Regulations in 2014. Took part in the compilation of supporting textbook of pharmaceutical process design of nation excellent course: Process Design of Pharmaceutical Engineering (second edition), which is the basic textbook for undergraduate majors such as Pharmaceutical Engineering and Medicinal Preparation. 2012年主持编写并出版《制药工艺验证实施手册》，率先将先进的国际理念与制药行业验证实践完美结合。2013年参与编写并出版了《制药洁净室微生物控制》、《制药流体工艺实施手册》两本专业著作；2014年参与编写并出版了《欧盟GMP/GDP法规汇编》，同时参与编写了国家精品课程制药工艺设计配套教材：制药工程工艺设计（第2版），本书是全国《制药工程》、《药物制剂》等本科专业的基础教材。
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发表于 2014-10-8 22:06:01
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，你也是我偶像。