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Speakers

Paving the Way to Validation Excellence

October 22-24, 2018
  • San Diego, CA

Maneesha Altekar
Senior Technical Manager
AstraZeneca

Gamal Amer, PhD
Principal
Premier Compliance Services, Inc.

Michael Branch
Senior Director, Global IT QA & Compliance
Medtronic

Raymond Brullo, DPM
Compliance Officer, Office of Regulatory Affairs
U.S. Food and Drug Administration

Joe Cagnassola
Principal Validation Engineer
Novartis

David L. Chesney
Principal and General Manager
DL Chesney Consulting, LLC

Jorge A. Cordero, BSChE, MBA-GM
Principal Validation Engineer
Bausch + Lomb

Rod Freeman, BS, MS
Global Process Owner, Process Validation
Beckman Coulter

Brent Gendleman
Innovation and Technology Adoption
Azzur Group

Karen Ginsbury
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd

Roberta Goode, MSBE, CQE
Altrec, LLC

Janine Hanson
Head of Q&R Software Management, Senior Director
Philips

Jeff Hanson
Manager, Validation
Upsher-Smith

Connie Hetzler
Global Head of Validation, Manufacturing Science & Technology
Alcon Laboratories, a division of Novartis

Lou Killian
Director, Customer Education and Success
Kneat Software

Valarie King-Bailey
Chief Executive Officer
OnShore Technology Group

Michael C. Korbel, BS Biology
Senior Compliance Consultant
Agilent Technologies Inc.

Michael Loiterman
U.S. Head of Regulatory Affairs, Quality Assurance & Quality Control
Richard Wolf Medical Instruments

Raymond McKinney, BEng, MBA
Director
NNIT Inc.

Frank Melendandri Sr., MBA Six Sigma Black Belt
Manager, Quality Assurance
Zoll

Rick Mineo
Vice President
Encova

Delores Morrison
Engineering Director, Global Validation
Edwards Life Sciences

Khaled Moussally
Head Quality Management Systems & Managing Partner
Compliance Group

J. Sean Osso
Consulting Engineer/Quality Engineer
Osso2 Consulting Group and TMJ Concepts

Lou Poirier
IT Manager
Medtronic

Paul L. Pluta, PhD
Editor-in-Chief, Journal of Validation Technology and Journal of GXP Compliance
IVT Network/UBM Americas

Lizzandra Rivera
Associate Director, IT Quality
Alexion Pharmaceuticals

Laurent Saugrin
Computer Validation Specialist IV, IT Compliance
Dexcom

Jason Spiegler
Senior Director, Industry Portfolio Development
Siemens Product Lifecycle Management Software Inc.

Doug Shaw
Director, CSV & IT Consulting
Azzur Group

Linda Thai
Consumer Safety Officer, Office of Regulatory Affairs
U.S. Food and Drug Administration

Steve Thompson
Senior Manager, Professional Services
ValGenesis, Inc.

Eric Toburen
Managing Partner
Tx3 Services LLC

Francisco Vicenty
Program Manager, Case for Quality, CDRH
U.S. Food and Drug Administration

Mihir Vashi
Validation Lead
Alcon, a Division of Novartis

Chris Wubbolt
Principal Consultant
QACV Consulting, LLC

Joseph Zec
Associate Director, CSV and Compliance
Shire plc

Maneesha Altekar
Senior Technical Manager
AstraZeneca

Gamal Amer, PhD
Principal
Premier Compliance Services, Inc.

Michael Branch
Senior Director, Global IT QA & Compliance
Medtronic

Raymond Brullo, DPM
Compliance Officer, Office of Regulatory Affairs
U.S. Food and Drug Administration

Joe Cagnassola
Principal Validation Engineer
Novartis

David L. Chesney
Principal and General Manager
DL Chesney Consulting, LLC

Jorge A. Cordero, BSChE, MBA-GM
Principal Validation Engineer
Bausch + Lomb

Rod Freeman, BS, MS
Global Process Owner, Process Validation
Beckman Coulter

Brent Gendleman
Innovation and Technology Adoption
Azzur Group

Karen Ginsbury
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd

Roberta Goode, MSBE, CQE
Altrec, LLC

Janine Hanson
Head of Q&R Software Management, Senior Director
Philips

Jeff Hanson
Manager, Validation
Upsher-Smith

Connie Hetzler
Global Head of Validation, Manufacturing Science & Technology
Alcon Laboratories, a division of Novartis

Lou Killian
Director, Customer Education and Success
Kneat Software

Valarie King-Bailey
Chief Executive Officer
OnShore Technology Group

Michael C. Korbel, BS Biology
Senior Compliance Consultant
Agilent Technologies Inc.

Michael Loiterman
U.S. Head of Regulatory Affairs, Quality Assurance & Quality Control
Richard Wolf Medical Instruments

Raymond McKinney, BEng, MBA
Director
NNIT Inc.

Frank Melendandri Sr., MBA Six Sigma Black Belt
Manager, Quality Assurance
Zoll

Rick Mineo
Vice President
Encova

Delores Morrison
Engineering Director, Global Validation
Edwards Life Sciences

Khaled Moussally
Head Quality Management Systems & Managing Partner
Compliance Group

J. Sean Osso
Consulting Engineer/Quality Engineer
Osso2 Consulting Group and TMJ Concepts

Lou Poirier
IT Manager
Medtronic

Paul L. Pluta, PhD
Editor-in-Chief, Journal of Validation Technology and Journal of GXP Compliance
IVT Network/UBM Americas

Lizzandra Rivera
Associate Director, IT Quality
Alexion Pharmaceuticals

Laurent Saugrin
Computer Validation Specialist IV, IT Compliance
Dexcom

Jason Spiegler
Senior Director, Industry Portfolio Development
Siemens Product Lifecycle Management Software Inc.

Doug Shaw
Director, CSV & IT Consulting
Azzur Group

Linda Thai
Consumer Safety Officer, Office of Regulatory Affairs
U.S. Food and Drug Administration

Steve Thompson
Senior Manager, Professional Services
ValGenesis, Inc.

Eric Toburen
Managing Partner
Tx3 Services LLC

Francisco Vicenty
Program Manager, Case for Quality, CDRH
U.S. Food and Drug Administration

Mihir Vashi
Validation Lead
Alcon, a Division of Novartis

Chris Wubbolt
Principal Consultant
QACV Consulting, LLC

Joseph Zec
Associate Director, CSV and Compliance
Shire plc