14th Annual FDA Inspections Summit

FDA Inspections Summit Planning Committee Chairs

John AvellanetJohn Avellanet

Managing Director and Principal, Cerulean Associates LLC

John's Bio

Susan Leister, PhDSusan Leister

Vice-President, Quality & Compliance, Technical Resources International

Susan's Bio

Brian LudovicoBrian Ludovico

Executive Director, MDSAP Regulatory Certification, NSF Health Sciences

Brian's Bio

Steve NiedelmanSteve Niedelman

Lead Quality Systems and Compliance Consultant, King and Spalding LLP

Steve's Bio

Dan O'LearyDan O'Leary

President, Ombu Enterprises LLC

Dan's Bio

Cynthia SchnedarCynthia Schnedar

Executive Vice President, Regulatory Compliance, Greenleaf Health; former Director of the Office of Compliance, CDER, FDA

Cynthia's Bio

Susan SchnieppSusan Schniepp

Fellow, Regulatory Compliance Associates, Inc.

Susan's Bio

Featured FDA Speaker

Mark AbdooMark Abdoo

Associate Commissioner for Global Policy and Strategy, OC, FDA

Mark's Bio


David Borasky, Vice President, IRB Compliance, WIRB-Copernicus Group

Chrissy Cochran, PhD, Director, Office of Bioresearch Monitoring Operations, OMPTO, ORA, FDA (Invited)

Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, ORA, FDA (Invited)

Reetu Dandora, Executive Director, Merck Research Laboratories Quality Assurance

Kristen Grumet, Senior Vice President, Regulatory Compliance, Greenleaf Health; former FDA Field Investigator specializing in medical devices

Connie Hoy, Consultant, Hoy & Associates Regulatory Consulting

Ginette Michaud, Director, Office of Biological Products Operations at ORA, FDA (Invited)

Phil Pontikos, Device National Expert Investigator with ORA, FDA (Invited)

Sharon Reinhard, Executive Director, Merck

Karl Vahey, Vice President Manufacturing Quality, Cardinal Health

Jan Welch, Director, Office of Medical Device and Radiological Health Operations, ORA, FDA (Invited)

Marc-Henri Winter, Staff Fellow, Division of International Compliance Operations, OC, CDRH, FDA (Invited)

Liz Wool, President, Wool Consulting Group, Inc.