Louise Tan, BSc (Biochemistry)
Quality Assurance & Regulatory Affairs Specialist
With over 25 years of experience in biopharmaceutical companies that had products enter phase III clinical trials, Louise has extensive working knowledge in setting up and implementing Quality Management System (QMS), Quality Control and validation programs that comply with Good Manufacturing Practices (GMP) from various jurisdictions (FDA, Health Canada, EU, ICH, WHO) for mammalian, bacterial, and insect cell lines, as well as implementing ISO 15189 Standards for Medical Laboratory. At the AVI, Louise manages the Quality Assurance, Quality Control and Regulatory Affairs department where she assures quality is built into the Hepatitis C vaccine product.
Office Location:7-126 Li Ka Shing Center for Health and Research Innovation
Contact Phone: 780.492.8052