Chair, General Chapters–Measurement & Data Quality Expert Committee
Career Highlights:
- Zinata Inc.: Business Consultant - Senior Quality Expert
- Valeant Pharmaceuticals: Director, Laboratory Services
- Watson Laboratories, Inc.: Associate Director Laboratory Operations
- Independent Consultant
Education:
- University of Manitoba, B.Sc., Chemistry
- University of Manitoba, Quality Assurance Management Certificate
- American Society for Quality, Certificates in Quality Engineering and Quality Management
Awards, Recognition, Admissions:
- Journal of Validation Technology’s Author of the Year Award 2014, 2018
- Chair: USP Expert Committee, Measurement and Data Quality
- Fellow: AOAC International
A Few Favorite Professional Achievements:
- Leading the quality effort in developing and obtaining FDA approval for three products included in the U.S. Strategic National Stockpile: Heptavalent botulism antitoxin, Vaccinia immune globulin, Anthrax immune globulin.
- Directing a Quality Control team in responding to an FDA consent decree by validating over 200 methods
- Being chair of the USP Expert Committee responsible for the publication and implementation of the new General Chapter <1220> Analytical Procedure Life Cycle
- Publication of USP General Chapter <1220> Analytical Procedure Life Cycle
- Received the Journal of Validation Technology’s Author of the Year Award 2018 for a paper on “Analytical Quality by Design”
- Created a laboratory accreditation program for the mining industry in 1990s that is still being used
- Taking the Quality Department of a small, one-product pharmaceutical company to supporting a multi-product proprietary and contract manufacture
