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江明:计算机化系统及数据完整性管理的良好实践

作者:本网编辑 文章来源:PHT《制药业》 点击数:34 发布时间:2017-06-12
江明,上海朗脉洁净技术股份有限公司GMP咨询经理/高级验证工程师...
江明:计算机化系统及数据完整性管理的良好实践

江明,上海朗脉洁净技术股份有限公司GMP咨询经理/高级验证工程师

上海朗脉 GMP咨询&验证事业部 GMP咨询部经理/高级验证工程师

在制药行业拥有超过十三年的质量管理、生产管理和验证经验,其中6年第三方GMP咨询和验证合规性服务经验。曾在多家外资合资企业、大型国企主管GMP合规、验证与生产工作。现任上海朗脉洁净技术股份有限公司 GMP咨询部经理和高级验证工程师。承担并完成了多个大型制药企业和合资药厂的国际认证和验证项目,涉及疫苗、血液制品、无菌制剂、固体制剂原料药等产品的验证及GMP合规性咨询服务。在质量管理体系、第三方审计、工艺验证、清洁验证、计算机化系统验证、计算机化系统管理和电子数据管理等领域拥有丰富的经验。

 

Jiang Ming(Elton Jiang) has been engaged in the pharmaceutical industry for 13 years with an experience in GMP and validation service for 6 years. Now he is a GMP Consultant Manage & Senior Validation Engineer of Shanghai MacropeocessCo.,Ltd. He has ever undertaken and accomplished a number of international certification and validation projects for numerous large domestic pharmaceutical enterprises and joint ventures and such validation projects involve validation services for all such products as vaccines, biological products, sterile products, solid dosage forms and APIs, and GMP conformance service. He has extensive experience in Pharmaceutical Quality Systems, Third party audit, process validation, cleaning Validation, computerized systems validation and manage of computerized systems/date integrity.