Nancy Singer, JD, LLM, RAC, FRAPS founded Compliance-Alliance LLC to specialize in the professional development of government and business professionals in regulated industries. She is an associate professor at the USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences and was on the faculty at George Washington School of Medicine and Health Sciences. She presently teaches classes for the FDA Staff Colleges and the FDA Program District Offices. Previously, she served as Special Counsel for the Advanced Medical Technology Association. For her efforts to improve communication between the government and the regulated industry, Nancy received Vice President Gore’s Reinventing Government Hammer Award and the FDA Commissioner’s Special Citation. She began her career as an attorney with the Honors Program at the United States Department of Justice, doing litigation for FDA enforcement cases. Subsequently, she was a partner at the law firm of Kleinfeld Kaplan and Becker. Nancy received her BS from Cornell University and her JD and LLM degree from New York University Law School. She received her RAC certification from the Regulatory Affairs Professional Society (RAPS). She was selected as a RAPS fellow. She has been an industry advisor to the Board of Directors of the Association of Food and Drug Officials. Nancy spent 21 years in the Naval Reserve and retired as a commander.

Richard DeRisio collaborates on the development and presentation of training courses for regulatory affairs and quality system professionals.  Early in his career, Richard worked in FDA’s Washington-area headquarters offices supporting field operations, managing foreign inspections of medical device and pharmaceutical manufacturers and, in CDRH’s Office of Compliance, reviewing compliance actions, conducting industry training, and serving as the organization’s sterilization sciences expert. After serving at FDA and during his career in the pharmaceuticals, diagnostics and medical devices industries, Richard led global and divisional clinical, quality, regulatory, government affairs and operations organizations at Abbott, J&J, Covidien, and Pfizer, among other companies.  His experience encompasses cardiothoracic, electrophysiology, robotic, ophthalmology, and wound healing devices. Richard was VP, Medical Health Services, Americas Region for the German Notified Body, TÜV SÜD.  In that role, Richard’s organization was responsible for CE-Mark approval of medical devices manufactured in North America.  Richard attended Cornell University where he received a B.S. degree in chemical engineering and an M.S. degree in food science and technology.  He has served as an industry representative on the Association for the Advancement of Medical Instrumentation Board of Directors and cochaired the Standards Board, Government Affairs Board and two industrial sterilization standards committees.  Richard has made presentations to students in the USC Regulatory Science Graduate Program, published in Medical Device & Diagnostic Industry magazine, and spoken at UBM/Canon Medical Design and Manufacturing Conferences, among others.