12th Annual FDA Inspections Summit


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

Mark BrownMark Brown

Partner, King & Spalding

Mark's Bio

David ChesneyDavid Chesney

Principal and General Manager, DL Chesney Consulting LLC

David's Bio

Dara Corrigan, J.D.Dara Corrigan, J.D. (Invited)

Associate Commissioner, Office of Global Regulatory Operations and Policy, OC, FDA

Dara'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

Ellen MorrisonEllen Morrison

Associate Commissioner, OMPTO, ORA, FDA

Ellen's Bio

Robin NewmanRobin Newman (Invited)

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

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

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, Patient Monitoring and Recovery, MITG, Medtronic

Karl's Bio