China NMPA GMP/GDP/GCP regulations
Shirley joined Qserve in 2018 as Principal Consultant, to support clients in their QMS compliance, and to help prepare for Chinese overseas inspections with mock-audits, training and coaching.
Shirley has 35+ years working experience in Pharma/Device industry focusing on global QMS implementation & China regulatory compliance, among which including 20 years for Multi-national companies; She’s the specialist of NMPA (former) CFDA GMP/GSP/GCP regulatory compliance & registration for pharmaceutical & Medical devices; qualified auditor & tutor of the 3rd party (BSI).
She holds EMBA of Beijing University, Bachelor degree in Biology of Beijing Normal University, studied Pharmaceutical in Beijing Pharma-Tech college & English HC in Beijing Foreign Language University.
The key expertise areas of Shirley:
- Principal Consultant for China NMPA overseas inspection for medical device (Chinese GMP consultant and mock audit)
- China NMPA GMP/GSP/GCP/GLP regulatory compliance for Medical Devices and Pharmaceuticals
- ISO9001, ISO13485, ISO14971
- FDA Medical Device (QSR820), Pharmaceutical (GMP)
- Lead auditor for global pharmaceutical auditing program (Rx360)
- ICH Q7/Q10
- EU MDD/IVDD/MDR/IVDR
- NMPA Pharmaceuticals and Medical Device Product Registration
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