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


Speakers

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.