Sarah Tanksley, president and CEO of Tanksley Consulting Group, is a former FDA investigator with almost 25 years of experience in the FDA, NIH and various consulting firms. She began her career as a government biologist with the U.S. Army, then later with NIH and finally as a reviewer and inspector with the Center for Biologics Evaluation and Research’s Office of Compliance. She is an adjunct professor in good manufacturing practice (GMP) and regulatory compliance for Georgetown University School of Medicine and Johns Hopkins University. She has trained audiences worldwide on GMP, inspection readiness and data integrity topics.