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Speakers

Data Integrity • Method Transfers and Validation • Stability Testing

December 4-6, 2019
  • Philadelphia, PA

Abhishek Bachchan
Senior Manager, Global IT Compliance
ThermoFisher Scientific

Geoff Carr
Director of Analytical Development, Ontario
Patheon by ThermoFisher Scientific

Aili Cheng
Pharm Sci & PGS Statistics,
Worldwide Research and Development
Pfizer Inc

Alyce Deegan
Vice President of Data Integrity Practice
Compliance Path LLC

Karen Ginsbury, BPharm, MSc
Founder and CEO
PCI Pharma Ltd.

Alan Golden
Principal, Design Quality Consultants, LLC;
former Principal Quality Professional, Abbott Molecular

Shilpi Guliani,
Associate Director, IT Quality Engineering
Gilead Sciences

Maria Krisch, PhD
Senior Scientist
FreeThink Technologies, Inc.

Sangeeta M. Khurana, PhD
Interdisciplinary Scientist/Investigator (GDUFA),
Office of Pharmaceutical Quality Operations (OPQO) – Division 4,
Office of Medical Products and Tobacco Operations, ORA
U.S. Food and Drug Administration

John O’Neill, MS, RPh
Stability Information Specialist
StabilityHub

Libby Russell
Senior Vice President
Neva Analytics

Ronald D. Snee, PhD
President, Consultant
Snee Associates, LLC

Emily Trubee
Stability Manager, R&D
ADARE Pharmaceuticals

Balaji Viswanathan, PhD
Principal Scientist Method Validation,
Validation and Analytical Technology Transfer (VATT),
Biotherapeutics Pharmaceutical Sciences
Pfizer Inc

Jane Weitzel, MS
Independent Consultant

Sheba Zaman
Head of Product Specialists and Training Services
Novatek International

Ben Zarza
Site Validation Manager
ThermoFisher Scientific

Abhishek Bachchan
Senior Manager, Global IT Compliance
ThermoFisher Scientific

Geoff Carr
Director of Analytical Development, Ontario
Patheon by ThermoFisher Scientific

Aili Cheng
Pharm Sci & PGS Statistics,
Worldwide Research and Development
Pfizer Inc

Alyce Deegan
Vice President of Data Integrity Practice
Compliance Path LLC

Karen Ginsbury, BPharm, MSc
Founder and CEO
PCI Pharma Ltd.

Alan Golden
Principal, Design Quality Consultants, LLC;
former Principal Quality Professional, Abbott Molecular

Shilpi Guliani,
Associate Director, IT Quality Engineering
Gilead Sciences

Maria Krisch, PhD
Senior Scientist
FreeThink Technologies, Inc.

Sangeeta M. Khurana, PhD
Interdisciplinary Scientist/Investigator (GDUFA),
Office of Pharmaceutical Quality Operations (OPQO) – Division 4,
Office of Medical Products and Tobacco Operations, ORA
U.S. Food and Drug Administration

John O’Neill, MS, RPh
Stability Information Specialist
StabilityHub

Libby Russell
Senior Vice President
Neva Analytics

Ronald D. Snee, PhD
President, Consultant
Snee Associates, LLC

Emily Trubee
Stability Manager, R&D
ADARE Pharmaceuticals

Balaji Viswanathan, PhD
Principal Scientist Method Validation,
Validation and Analytical Technology Transfer (VATT),
Biotherapeutics Pharmaceutical Sciences
Pfizer Inc

Jane Weitzel, MS
Independent Consultant

Sheba Zaman
Head of Product Specialists and Training Services
Novatek International

Ben Zarza
Site Validation Manager
ThermoFisher Scientific