David K. Elder Greenleaf Health
David K. Elder Greenleaf Health
A 23-year veteran of the FDA and retired Captain in the U.S. Public Health Service (USPHS), David last served as a senior FDA official with prominent roles in domestic and foreign inspections; recalls and emergencies; and compliance actions involving hundreds of situations. He has testified for FDA in federal court and before Congress, initiated and approved enforcement actions, conducted and directed inspections, trained hundreds of FDA investigators, and represented the FDA during national media events. From 1988-2003, David served as an Investigator, Compliance Officer and Compliance Branch Director in the Boston District Office. From 2003-2012, David served in two Senior Executive Service positions at FDA headquarters: Director of the Office of Enforcement (leading the Office with responsibility for compliance policy, enforcement case development, and product recalls), and Director of the Office of Regional Operations (leading the Office with responsibility for policy and operations related to foreign and domestic inspections, import operations, field science, and emergency response). Since leaving FDA in 2012, David has been providing strategic consulting services to pharmaceutical and device companies worldwide, first serving as Vice President with PAREXEL International and for the past four years as Executive Vice President with Greenleaf Health.