Larry Spears, president of L. Spears Consulting LLC, spent 34 years at the U.S. Food and Drug Administration (1977–2011); his last position was Deputy Director for Regulatory Affairs. He also served as Director and Deputy Director of the Division of Enforcement as well as Compliance Officer where he gained extensive knowledge and experience in the application of FDA law, regulations, and policy relating to compliance and enforcement programs and strategy. He most recently was director in enterprise risk services for life sciences at a Big Four consulting firm, where he helped clients develop quality and risk strategies in regulatory governance, contract manufacturing, and validation.