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.
Qualified Instructor