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Tuesday, Nov. 17 – Wednesday, Nov. 18, 2020

#1 Event for Quality, Compliance and Regulatory Professionals

2019 Faculty Included Experts From FDA and Industry


FDA Speakers and Panelists

  • Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, ORA, FDA
  • CAPT Helen Saccone, Senior Advisor, Office of Strategic Programs, CDER, FDA


Former FDA Speakers and Industry Experts

  • John Avellanet, Managing Director and Principal, Cerulean Associates
  • David Borasky, Vice President of IRB Compliance, WIRB-Copernicus Group
  • Chalana Damron, Counsel, Crowell & Moring
  • David Elder, Executive Vice President, Greenleaf Health
  • Kristen Grumet, Senior Vice President, Regulatory Compliance, Greenleaf Health
  • Connie Hoy, Consultant, Hoy & Associates Regulatory Consulting
  • Susan Leister, Vice President of Quality & Compliance, Technical Resources International
  • Brian Ludovico, Executive Director, MDSAP Regulatory Certification, NSF Health Sciences
  • Steven Lynn, Principal GxP Consultant/Owner, Lynn Consulting
  • Chris Markus, Partner and Deputy Chair, FDA & Life Sciences Practice, King & Spalding
  • John McKay, CEO and Chief Compliance Officer, Q1 Associates
  • Steve Niedelman, Lead Quality Systems and Compliance Consultant, King & Spalding
  • Dan O'Leary, President, Ombu Enterprises
  • Sharon Reinhard, Executive Director, Merck
  • Marc Scheineson, Partner, Alston & Bird
  • Cynthia Schnedar, Executive Vice President, Regulatory Compliance, Greenleaf; former Director of the Office of Compliance, CDER, FDA
  • Susan Schniepp, Fellow, Regulatory Compliance Associates, Inc.
  • Ibim Tariah, Vice President, EU MDR and IVDR Consulting Services, Regulatory & Quality Solutions
  • John Taylor, President/Principal, Compliance and Regulatory Affairs, Greenleaf Health
  • Karl Vahey, Vice President Manufacturing Quality, Cardinal Health
  • Liz Wool, President, Wool Consulting Group


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