12th Annual FDA Inspections Summit

Speakers

John AvellanetJohn Avellanet

Managing Director and Principal, Cerulean Associates LLC



John's Bio


Katlin BackfieldKatlin Backfield

Attorney at Law, Consultant, Backfield PLLC



Katlin's Bio


Carol Bennett, JDCarol Bennett, J.D. (Invited)

Deputy Director, Office of Regulatory Policy, CDER, FDA




David ChesneyDavid Chesney

Principal and General Manager, DL Chesney Consulting LLC



David's Bio


Connie HoyConnie Hoy

Executive Vice President of RA/QA, Cynosure



Connie's Bio


Julie LarsenJulie Larsen

Senior Partner, Director Inspection Readiness Services, BioTeknica


Julie's Bio


Peter LeiningerPeter Leininger

Counsel, King & Spalding; former Associate Chief Counsel for Enforcement in FDA’s Office of Chief Counsel



Peter's Bio


Niraj MehtaNiraj Mehta, Ph.D.

Associate Director for Global Regulatory Policy, Office of Global Regulatory Operations and Policy, OC, FDA


Niraj's Bio


Ellen MorrisonEllen Morrison

Associate Commissioner, OMPTO, ORA, FDA



Ellen's Bio


Robin NewmanRobin Newman

Director, Office of Compliance, CDRH, FDA



Robin'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


Braulio OrtizBraulio Ortiz

Principal/Project Manager/Senior Quality Engineer, BioTeknica, Inc.


Braulio's Bio


Marla A. PhillipsMarla A. Phillips, Ph.D.

Director, Xavier Health, Xavier University; former Head of Quality at Merck’s North Carolina facility


Marla's Bio


Cynthia SchnedarCynthia Schnedar

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


Cynthia's Bio


Susan SchnieppSusan Schniepp

Fellow, Regulatory Compliance Associates, Inc.



Susan's Bio


Lenita Y. Sims SpearsLenita Y. Sims Spears

Senior Quality Consultant/Senior Regulatory and Compliance Counsel, BioTeknica



Lenita's Bio


Douglas StearnsDouglas Stearns (Invited)

Director, Office of Enforcement and Import Operations, ORA, FDA


Douglas' Bio


Vicky StoakesVicky Stoakes

President, IntegRx, Inc.; former FDA Chemist, ACNA and Investigator, Atlanta District Office Drug Cadre


Vicky's Bio


Ibim Tariah, Ph.D.Ibim Tariah, Ph.D.

Technical Director, BSI Americas Inc.



Ibim's Bio


Karl VaheyKarl Vahey

Vice President Manufacturing Quality, Cardinal Health



Karl's Bio