陈国笋
Chen Guosun
上海朗脉洁净技术股份有限公司
GMP咨询和验证事业部
总经理
Macroprocess (Shanghai) Lustration Technology Co., Ltd.
GMP Consulting and Validation Business Unit
General Manager
有着15年的制药行业经验,曾先后在制药公司、GMP咨询公司、制药工程公司担任重要职位,从事有关生产质量管理和验证方面的工作。熟悉中国、美国和欧盟GMP法规和指南,对验证有丰富的实践经验,尤其是验证管理、HVAC系统的确认、水系统的确认、设备确认和工艺验证,以及计算机化系统验证。
Has over 15 years of experience in Pharmaceutical Industry. Worked for pharmaceutical company, GMP consulting company and pharmaceutical engineering company in important positions, engaged in the production and quality management and validation work. Be familiar with Chinese, USA and EU GMP Regulations and Guidance. Has rich practical experience in Qualification and Validation, especially in Validation management, HVAC system qualification, Water system qualification, process equipment qualification and process validation, as well as computerized system validation.
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