Robert Tollefsen

  PhotoRobert Tollefsen is the National Expert Investigator for Computer Systems in the Division of Field Investigations within the Office of Regulatory Affairs in FDA. He began his career in FDA in 1991 as a chemist in the drug section of what is now FDA's Pacific Regional Laboratory Northwest. Tollefsen is called upon to participate in FDA’s more complex inspections of primarily drug and biotech companies across the US and throughout the world. He is an instructor at numerous national training courses for FDA investigators and FDA analysts to include; pre-approval investigations (advanced drug school), basic drug school, orientation to international inspections, computer system validation, introduction to inspections of pharmaceutical laboratories and computer aided inspections. He has given presentations at numerous academic and industry seminars across the US and internationally and has participated as an instructor at the University of Washington's course on biomedical regulatory affairs. Tollefsen received his BS with double majors in chemistry and biology and minor in mathematics from Eastern Washington University with honors.