13th Annual FDA Inspections Summit

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
  • Steve Niedelman, Lead Quality Systems and Compliance Consultant, King and Spalding, former FDA Deputy Associate Commissioner for Regulatory Operations
  • 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