Pat is a GxP Quality Systems and Regulatory Compliance consultant, based in Hamilton, Ontario, Canada. She is a Medical Laboratory Technologist with more than 40 years of experience in the health-care and pharmaceutical/biologics manufacturing and consulting industries, including over 20 years in Quality and Compliance. Prior to returning to private consulting, Pat was the Associate Director, Compliance, Clinical Services at CanReg Inc. Pat’s primary focus is compliance auditing and training in the areas of GCP, GMP, GLP, ISO (medical devices) and related Quality Systems. She has performed sponsor, clinical site, and manufacturing due diligence, supplier qualification, and general compliance audits in Canada, US, and Europe, and delivered training courses to public and company-specific audiences. Pat holds certifications from the Regulatory Affairs Professionals Society (RAPS) in Canadian, US, and European Regulatory Affairs, and acted as reviewer for the 2002 RAC Canada textbook. Pat is the Canadian Chapter President of the Association of Clinical Research Professionals (ACRP), and also serves on the Global Membership and Professional Development Committees of ACRP.     [ Click for More ]

Pat is a GxP Quality Systems and Regulatory Compliance consultant, based in Hamilton, Ontario, Canada. She is a Medical Laboratory Technologist with more than 40 years of experience in the health-care and pharmaceutical/biologics manufacturing and consulting industries, including over 20 years in Quality and Compliance. Prior to returning to private consulting, Pat was the Associate Director, Compliance, Clinical Services at CanReg Inc. Pat’s primary focus is compliance auditing and training in the areas of GCP, GMP, GLP, ISO (medical devices) and related Quality Systems. She has performed sponsor, clinical site, and manufacturing due diligence, supplier qualification, and general compliance audits in Canada, US, and Europe, and delivered training courses to public and company-specific audiences. Pat holds certifications from the Regulatory Affairs Professionals Society (RAPS) in Canadian, US, and European Regulatory Affairs, and acted as reviewer for the 2002 RAC Canada textbook. Pat is the Canadian Chapter President of the Association of Clinical Research Professionals (ACRP), and also serves on the Global Membership and Professional Development Committees of ACRP.