13th Annual FDA Inspections Summit

CO-CHAIRS

Steve NiedelmanSteve Niedelman

Lead Quality Systems and Compliance Consultant, King and Spalding LLP


Steve's Bio


David A. BoraskyDavid A. Borasky

Vice President of IRB Compliance, WIRB-Copernicus Group (WCG)


David's Bio


Robert RuffRobert Ruff

Executive Director of Medical Device Education and Training, International MDSAP Team Lead, NSF Health Sciences


Robert's Bio


Susan SchnieppSusan Schniepp

Fellow, Regulatory Compliance Associates, Inc.



Susan's Bio


PRECONFERENCE WORKSHOP LEADERS

John AvellanetJohn Avellanet

Managing Director and Principal, Cerulean Associates LLC



John's Bio


Susan Leister, PhDSusan Leister, PhD

Vice-President of Quality & Compliance of Technical Resources International


Susan's Bio


Dan O'LearyDan O'Leary

President, Ombu Enterprises LLC



Dan's Bio


SPEAKERS

Kalah Auchincloss, J.D.Kalah Auchincloss, J.D.

Senior Vice President, Regulatory Compliance and Deputy General Counsel, Greenleaf Health


Kalah's Bio


Alexander CrosbyAlexander Crosby

Americas Program Manager, Medical Business Assurance, Intertek



Alonza CruseAlonza Cruse

Director, Office of Pharmaceutical Quality Operations, ORA, FDA (invited)


Alonza's Bio


David GlasgowDavid Glasgow

Deputy Director, Office of Bioresearch Monitoring Operations, OMPTO, ORA, FDA


David's Bio


Cassandra KennedyCassandra Kennedy

VP, Global Head, Regulatory Compliance and Quality Assurance, Covance


Cassandra's Bio


Phillip LeesePhillip Leese

President, Medical Consultants PA (invited)



Phillip's Bio


Alex John LondonAlex John London

Clara L. West Professor of Ethics and Philosophy and Director of the Center for Ethics and Policy, Carnegie Mellon University


Alex John's Bio


Brian LudovicoBrian Ludovico

Executive Director, MDSAP Regulatory Certification, NSF Health Sciences


Brian's Bio


Steve McCarthySteve McCarthy

Vice President of Digital Innovation, Sparta Systems



Steve's Bio


Ellen MorrisonEllen Morrison

Associate Commissioner, OMPTO,ORA, FDA



Ellen's Bio


Marla PhillipsMarla Phillips

Director, Xavier Health, Xavier University



Marla's Bio


Cynthia SchnedarCynthia Schnedar

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


Melinda's Bio


Linda SullivanLinda Sullivan

Executive Director, Metrics Champion Consortium



Linda's Bio


Ronald TetzlaffRonald Tetzlaff

Corporate Vice President, PAREXEL Consulting



Ronald's Bio


Karl VaheyKarl Vahey

Vice President Manufacturing Quality, Cardinal Health



Karl's Bio


Marc-Henri WinterMarc-Henri Winter

Staff Fellow, Division of International Compliance Operations, OC, CDRH, FDA



Marc-Henri's Bio