ISPE中国认证讲师

✅   2023年认证ISPE中国本地GAMP培训师

✅   GAMP 5第二版翻译项目经理兼技术负责人；西门子德国认证GMP专家

✅   在制药行业超过20多年的制药 CSV 和 GMP 的工作经验。

✅   熟悉制药行业，并根据监管要求和 GAMP 指南提供具体和完整的 CSV 和 GMP 的解决方案和实施方案。

✅   熟悉制药行业多个系统项目实施包括 SCADA 系统验证, PCS 系统验证, WMS 系统验证, LIMS 系统验证, ERP 系统验证, BMS/EMS 系统验证, DMS 系统验证, QMS 系统验证, XHQ 系统验证等。

✅   国家药品监督管理局计算机化系统验证培训师

Liwei Dong has over 15 years of experiences in the pharmaceutical industry. He is proficient in regulatory compliance of pharmaceutical products lifecycle from R&D to manufacturing of clinical batches till commercialized manufacturing, especially in the regulation framework of China, US, and EU.  He excels at establishing and maintaining quality systems, preparing and responding Health Authority legal enforcements, remediating and improving data integrity, auditing and for-cause investigating etc. He joined Parexel in 2018 as a Principal Consultant in Strategic Compliance Consulting, and provides GMP consultation to pharmaceutical and biotech customers worldwide, including to support clients to pass various inspections, to conduct EU QP audits, to execute or defend due diligence audits in license in/out projects, and to provide trainings etc. Prior to join Parexel, Liwei worked as Compliance Manager in Novartis.  Liwei has a bachelor’s degree on bioengineering at China Pharmaceutical University in the National Base of Life Science and Biotechnology Education.