13th Annual FDA Inspections Summit

2018 Chairperson

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