FDA Inspections vSummit

Alonza Cruse
Director, Office of Pharmaceutical Quality Operations, Office of Regulatory Affairs
FDA

Francisco Vicenty
Program Manager, Case for Quality
CDRH, FDA

Bleta Vuniqi
Associate Director
Office of Health Technology 4 (OHT4), Office of Product Evaluation and Quality (OPEQ), CDRH, FDA

Donald Ashley
Executive Vice President, Regulatory Compliance
Greenleaf Health

Deborah Autor
CEO
Autor Strategies, LLC

Ileana Barreto-Pettit
Vice President – Technical, Strategic Compliance Consulting
Parexel International

David Elder
Principal
Greenleaf Health, Inc.

Kristen Grumet
Senior Vice President of Regulatory Compliance
Greenleaf Health

Paula Katz
Of Counsel
Covington & Burling

Marie Mathews
Principal
Franklin Mathews Group

Massoud Motamed
Regulatory Expert
Healthcare Innovation Catalysts

Cynthia Schnedar
Principal
Greenleaf Health, Inc.

Howard Sklamberg
Partner
Arnold & Porter LLP

Peter Smith
Principal
Smith GMP Consulting

John Taylor
President; Principal of Regulatory Compliance
Greenleaf Health, Inc.

Kim Trautman
Managing Director and Vice President
MEDIcept, Inc.

Jason Brooke
Managing Member and Attorney
Brooke and Associates

Cathy Burgess
Partner
Alston & Bird

Dan Klassen
Vice President
Toscano Consulting Group

Sean Lloyd
Independent Quality Consultant
SRL Pharma LTD

Mariceles Mendoza
Managing Director
MFORCE3 Medical Device Consulting

Bob Rhoades
Managing Partner
Validant

Jaime Santana
President
Santana Quality Consulting

Sarah Tanksley
President and CEO
Tanksley Consulting Group Inc

James Vesper
Director, Learning Solutions
ValSource