14th Annual FDA Inspections Summit

2018 Faculty Included Experts From FDA and Industry:


FDA Speakers and Panelists

  • David Glasgow, Deputy Director, Office of Bioresearch Monitoring Operations, OMPTO, ORA, FDA
  • Ellen Morrison, Associate Commissioner, OMPTO,ORA, FDA
  • Marc-Henri Winter, Staff Fellow, Division of International Compliance Operations, OC, CDRH, FDA


Ex-FDA Speakers and Industry Experts

  • Kalah Auchincloss, Senior Vice President, Regulatory Compliance and Deputy General Counsel, Greenleaf Health
  • John Avellanet, Managing Director and Principal, Cerulean Associates LLC
  • David Borasky, Vice President of IRB Compliance, WIRB-Copernicus Group (WCG)
  • Maura Corcoran, Senior Director, Quality Operations, Ethicon Wound Closure Repair (JnJ)
  • Alexander Crosby, Americas Program Manager, Medical Business Assurance, Intertek
  • Quynh Hoang, Consultant, FDA and Life Sciences, King & Spalding
  • Cassandra Kennedy, VP, Global Head, Regulatory Compliance and Quality Assurance, Covance
  • Phillip Leese, President, Medical Consultants PA
  • Susan Leister, Vice-President of Quality & Compliance of Technical Resources International
  • Alex John London, Clara L. West Professor of Ethics and Philosophy and Director of the Center for Ethics and Policy, Carnegie Mellon University
  • Brian Ludovico, Executive Director, MDSAP Regulatory Certification, NSF Health Sciences
  • Steve McCarthy, Vice President of Digital Innovation, Sparta Systems
  • Anita Michael, Principal Consultant, PAREXEL Consulting
  • Susan Neadle, Sr. Director, Global Value Chain Quality Design, Head, J&J Combination Products CoP, Johnson & Johnson
  • Steve Niedelman, Lead Quality Systems and Compliance Consultant, King and Spalding LLP
  • Dan O'Leary, President, Ombu Enterprises LLC
  • Marla Phillips, Director, Xavier Health, Xavier University
  • Robert Ruff, Executive Director of Medical Device Education and Training, International MDSAP Team Lead, NSF Health Sciences
  • Marc Scheineson, Partner, Alston & Bird LLP
  • Cynthia Schnedar, Executive Vice President, Regulatory Compliance, Greenleaf; former Director of the Office of Compliance, CDER, FDA
  • Susan Schniepp, Fellow, Regulatory Compliance Associates, Inc.
  • David Shore, Quality Director, IDM, Eli Lilly and Company
  • Linda Sullivan, Executive Director, Metrics Champion Consortium
  • Ronald Tetzlaff, Corporate Vice President, PAREXEL Consulting
  • Karl Vahey, Vice President Manufacturing Quality, Cardinal Health