Biopharmaceutical Engineering Bachelor, MBA from Hong Kong University of Science and Technology, licensed pharmacist
With more than 15 years of industry background, Ms. Feng is proficient in microbiology, drug regulations and registration, GMP regulatory requirements of China, US and Europe and quality management system, also has accumulated profound experience in the Chinese pharmaceutical industry and GMP compliance consulting industry.
Ms. Feng leaded and implemented more than 100 compliance projects, including domestic and foreign audit and inspection work, EU/FDA/ICH/WHO GMP gap analysis for many large pharmaceutical companies, GMP consulting services for new plants and old plants upgrade, quality system establishment, technology transfer, etc.
Ms. Feng serviced customers covering China, US, India, Japan, South Korea, Thailand, Taiwan, etc., involving in the fields of aseptic products, chemical pharmaceutical preparations, API, radiopharmaceuticals, biological products and medical devices. Good at compliance strategy development, factory GMP planning, quality system establishment, compliance assessment, drug registration and MAH support.