cQMS review and evaluation
Completed cQMS review in 4 months for a Chinese biotech company including 30 SOPs in General, Project Management, Clinical Monitoring, Quality Control and Quality Assurance areas/departments, in order to facilitate company's cQMS upgrade.
Completed cQMS review in 3 months for a Chinese pharma company including 40 SOPs in R&D, Clinical Operations, Data Management, Statistics, Pharmacovigilance, Clinical Pharmacology, medical and Quality Assurance departments, in order to facilitate company's cQMS upgrade and prepare for the partner audit.
Inspection Management
Provided inspection management support in 4 months for Chinese health authority inspection on clinical project Of a global pharma company, including inspection preparation and training, onsite/remote support during the inspection, review and formulate responses to inspection findings.
Training
Provided customized training sessions to global pharma company, local biotech company, Local CRO company and clinical trial institution on the topics Of GCP refresh training, Good Documentation Practice, inspection management and investigator site audit for vaccine clinical trials.
Consulting
Provided QA consulting services to 3 local biotech companies regarding SOP development, issue management, CAPAs and quality culture.
