Steve Niedelman, Lead Quality Systems and Compliance Consultant, King and Spalding, former FDA Deputy Associate Commissioner for Regulatory Operations
2017 Faculty Included Experts From FDA and Industry:
FDA Speakers and Panelists
- Ellen Morrison, Associate Commissioner, OMPTO, ORA, FDA
- Niraj Mehta, Ph.D., Associate Director for Global Regulatory Policy, Office of Global Regulatory Operations and Policy, OC, FDA
- Douglas Stearns, Director, Office of Enforcement and Import Operations, ORA, FDA
- CAPT Sean Boyd, Deputy Director for Regulatory Affairs, Office of Compliance, CDRH, FDA
Ex-FDA Speakers and Industry Experts
- John Avellanet, Managing Director and Principal, Cerulean Associates LLC
- Katlin Backfield, Attorney at Law, Consultant, Backfield PLLC
- David Chesney Principal and General Manager, DL Chesney Consulting LLC
- Julie Larsen, Senior Partner, Director Inspection Readiness Services, BioTeknica
- Connie Hoy, Executive Vice President of RA/QA, Cynosure
- Peter Leininger, Counsel, King & Spalding; former Associate Chief Counsel for Enforcement in FDA’s Office of Chief Counsel
- Dan O’Leary, President, Ombu Enterprises
- Braulio Ortiz, Principal/Project Manager/Senior Quality Engineer, BioTeknica, Inc.
- Marla A. Phillips, Ph.D., Director, Xavier Health, Xavier University; former Head of Quality at Merck’s North Carolina facility
- Cynthia Schnedar, Executive Vice President, Regulatory Compliance, Greenleaf; former Director of the Office of Compliance, CDER, FDA
- Susan Schniepp, Fellow, Regulatory Compliance Associates, Inc.
- Lenita Y. Sims Spears, Senior Quality Consultant/Senior Regulatory and Compliance Counsel, BioTeknica
- Vicky Stoakes, President, IntegRx, Inc.; former FDA Chemist, ACNA and Investigator, Atlanta District Office Drug Cadre
- Ibim Tariah, Ph.D., Technical Director, BSI Americas Inc.
- Karl Vahey, Vice President Manufacturing Quality, Cardinal Health