I have a B.Sc. from the University of Alberta, am a Senior Member of the American Society for Quality, Certified Quality Auditor (CQA) through the American Society for Quality; Regulatory Affairs Certification (RAC) through the Regulatory Affairs Professional Society; and RQAP-GLP certification through the Society of Quality Assurance. I have held a series of management positions in Quality Assurance and Regulatory Affairs and also work as a consultant.
I have had a variety of experience being directly involved in FDA and Health Canada Audits in the areas of Medical Device Manufacturing, Drug Manufacturing and Testing, Drug and Device Establishments and Clinical Trial sites. Over the years I have gained experience with biologics, pharmaceuticals, medical devices, dietary supplements/natural health products and cosmetic ingredients. I have experience with a number of submissions to Health Canada and the FDA.