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Speakers

Paving the Way to Validation Excellence

October 16-18, 2019
  • Las Vegas, NV

Gamal Amer
Principal
Premier Compliance Services

Crystal Booth, MM
Regional Manager
PSC Biotech

Raymond W. Brullo, MD, DPM
Compliance Officer, Office of Medical Devices and Radiological
Health Operations Div. 3, Office of Regulatory Affairs (ORA)
U.S. Food and Drug Administration (USFDA) (Invited)

Javier Cardenas, PhD
Senior Consultant
Azzur Group

Harsha Chulki
Senior Validation Manager
ICU Medical

Stephen Cook
Senior Quality Manager
Compliance Group

Parsa Famili, MSc
President & CEO
Novatek International

Katherine Giacoletti, M. Stat
Partner
SynoloStats LLC

Alan Golden
Principal
Design Quality Consultants LLC

Gerardo Gómez, PhD
Senior Manager Business Development
PharmaLex

Senthil Gurumoorthi
Associate Director
Gilead

Connie Hetzler
Global Validation Head
Alcon Labs

Michelle Hickey
Director, Validation
Clovis Oncology

Derek Hughes
Vice President, US Sales
Kneat Solutions

Christopher Isham
Senior Director, Business Development for North America
PQE Group

William Johnson
Director Facilities & Validation
Bellicum Pharmaceuticals

Praveen Kalluri
Director, Quality Assurance – Computer System Validation
PTC Therapeutics

Valarie King-Bailey, MBA
Chief Executive Officer
OnShore Technology Group, Inc.

Shana Kinney
Senior Manager, Computer Systems Validation
REGENXBIO Inc.

Khaled Moussally
Head Quality Management Systems & Managing Partner
Compliance Group

J. Sean Osso
Quality Engineer – Expert
Agilent Technologies

Paul L. Pluta, PhD
Editor-in-Chief,
Journal of Validation Technology and Journal of GXP Compliance
IVT and Informa Connect;
Managing Director, Lifecycle Compliance Systems

Lizzandra Rivera
Assistant Director Quality – Systems,
Standards and Compliance, CSV Program Manager
Alexion

Mauricio Chinchilla Romero
Senior Quality Engineer
Edwards Lifesciences

Ravi Samavedam
General Manager
Azzur Group

Ken Shitamoto
Senior Director, IT
Gilead

Willis Thomas, PhD, PMP, CPT
Editorial Advisory Board Member
Journal of Validation Technology and Journal
of GXP Compliance

Kimberly A. Trautman, MS
Executive Vice President Medical Device International Services
NSF Medical Devices

Judy Umlas
Senior Vice President, Author, Trainer
International Institute for Learning, Inc.

Francisco Vicenty
Program Manager, Case for Quality Center for Devices and Radiological Health
U.S. Food and Drug Administration

Chris Wubbolt
Principal
QACV BioPharma Group

Gamal Amer
Principal
Premier Compliance Services

Crystal Booth, MM
Regional Manager
PSC Biotech

Raymond W. Brullo, MD, DPM
Compliance Officer, Office of Medical Devices and Radiological
Health Operations Div. 3, Office of Regulatory Affairs (ORA)
U.S. Food and Drug Administration (USFDA) (Invited)

Javier Cardenas, PhD
Senior Consultant
Azzur Group

Harsha Chulki
Senior Validation Manager
ICU Medical

Stephen Cook
Senior Quality Manager
Compliance Group

Parsa Famili, MSc
President & CEO
Novatek International

Katherine Giacoletti, M. Stat
Partner
SynoloStats LLC

Alan Golden
Principal
Design Quality Consultants LLC

Gerardo Gómez, PhD
Senior Manager Business Development
PharmaLex

Senthil Gurumoorthi
Associate Director
Gilead

Connie Hetzler
Global Validation Head
Alcon Labs

Michelle Hickey
Director, Validation
Clovis Oncology

Derek Hughes
Vice President, US Sales
Kneat Solutions

Christopher Isham
Senior Director, Business Development for North America
PQE Group

William Johnson
Director Facilities & Validation
Bellicum Pharmaceuticals

Praveen Kalluri
Director, Quality Assurance – Computer System Validation
PTC Therapeutics

Valarie King-Bailey, MBA
Chief Executive Officer
OnShore Technology Group, Inc.

Shana Kinney
Senior Manager, Computer Systems Validation
REGENXBIO Inc.

Khaled Moussally
Head Quality Management Systems & Managing Partner
Compliance Group

J. Sean Osso
Quality Engineer – Expert
Agilent Technologies

Paul L. Pluta, PhD
Editor-in-Chief,
Journal of Validation Technology and Journal of GXP Compliance
IVT and Informa Connect;
Managing Director, Lifecycle Compliance Systems

Lizzandra Rivera
Assistant Director Quality – Systems,
Standards and Compliance, CSV Program Manager
Alexion

Mauricio Chinchilla Romero
Senior Quality Engineer
Edwards Lifesciences

Ravi Samavedam
General Manager
Azzur Group

Ken Shitamoto
Senior Director, IT
Gilead

Willis Thomas, PhD, PMP, CPT
Editorial Advisory Board Member
Journal of Validation Technology and Journal
of GXP Compliance

Kimberly A. Trautman, MS
Executive Vice President Medical Device International Services
NSF Medical Devices

Judy Umlas
Senior Vice President, Author, Trainer
International Institute for Learning, Inc.

Francisco Vicenty
Program Manager, Case for Quality Center for Devices and Radiological Health
U.S. Food and Drug Administration

Chris Wubbolt
Principal
QACV BioPharma Group