Janis V. Olson is a senior validation consultant with EduQuest Inc., a global team of Food and Drug Administration compliance experts based near Washington, D.C. She worked at the FDA for more than 22 years, where among other responsibilities she conducted domestic and international inspections of FDA-regulated companies. Currently, Olson helps clients comply with GxP regulations worldwide. She is also a featured instructor at many conferences and training courses, including EduQuest’s popular “FDA Auditing of Computerized Systems and Part 11” course. The course, as well as other quality and risk management training, is also available from EduQuest on demand.