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current position:special project>>Vogel International Pharmaceutical Engineering Forum 2012

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作者: 文章来源:  点击数:1772  发布时间:2012-05-16

Deng Haigen

Senior Engineer,Licensed Pharmacist,born in Wuxi City on August 29, 1941,native of Wuxi City, Jiangsu Province; graduated from Chinese People's Liberation Army Antichemical Warfare Corps College in 1965.

Having served as Manager of the Quality Department of Sino-Swed Pharmaceutical Co., Ltd since 1984. Senior Advisor of China Pharmaceutical Association of Plant Engineering; participated in drafting China’s GMP; served as Adjunct Professor of Training Center of State Drug Administration.

In 1982,participated in translation of (Sino-Swed) Reliability Study of Sino-Swed Pharmaceutical Co., Ltd during work in Wuxi Municipal Pharmaceutical Research Institute; took part in preparing for establishment in Sino-Swed Company in January, 1983; attended the 2nd International GMP Seminar held in Sweden in the capacity of Manager of the Quality Department and received training on basic theory and practice concerning GMP in Sweden in 1984; in 1985, received internship involving lyophilized preparation and large volume parenteral (LVP) production management in Kabi Vitrum AB in Sweden, afterwards, engaged in internship relating to LVP production and quality management in Limoges, France; after returning to China, took charge of technical, quality, measurement and production validation work, and organized efforts to execute sterile product GMP in the Company.

Availed himself of the opportunities for investigation trip abroad, domestic and foreign exchange to gather mass data; participated in compiling the Guide for Pharmaceutical Manufacturing Validation (published by Chemical Industry Press) and worked as subeditor in 1996; served as Chief Editor of Practical Guide for GMP Management of Pharmaceutical Enterprise (published by China Metrology Press) for systematically introducing WHO’s GMP and application software in 1999; participated in compiling China’s GMP Implementation Guide (2001, published by Chemical Industry Press) in 2000; entrusted by Drug Certification Management Center of State Food and Drug Administration to serve as Chief Technical Examiner of the Guide for Pharmaceutical Manufacturing Validation (2003 Revision) and got involved in compiling General Rules for Drug GMP Inspection Guide in the same year; translated and edited EU GMP Guide (published by China Medical Science Press) in 2008.

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