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Speakers

Industry’s Gold-Standard for Validation Excellence

October 17-19, 2017
  • Philadelphia, PA

Gamal Amer, PhD
Principal
Premier Compliance Services, Inc.

Michael Barile
Founder and Managing Partner
Barile & Associates, Inc.

Karyn Campbell
Director, Investigations Branch II,
Division of Pharmaceutical Quality Operations I
FDA

Michael Cole
QA Validation Specialist III
B. Braun Medical Inc.

Parsa Famili
President and CEO
Novatek International

Tanya Fletcher-Scott, BS
Chemical Engineering, Director of Quality
Dendreon Pharmaceuticals

Alan Golden, MS
Principal Quality Professional,
Product Quality Operations Support
Abbott Molecular

Roberta Goode, MSBE, CQE
President
Goode Compliance International

Jim Gunning
Director, Quality CSV
Johnson & Johnson

Connie Hetzler
Global Validation Head
Alcon

Lou Killian
Director of Customer Success
Kneat Solutions

Valarie King-Bailey
CEO
OnShore Technology Group, Inc.

Carrie M. Kuehn, MPH, LPD, RAC
Senior Managing Scientist
Exponent, Inc.

Jerry Lanese, PhD
President
The Lanese Group, Inc.

Mohit Malkani
Director of Engineering Services
Bioteknica Inc.

Aida Markham, CQE, CQA
Vice President Compliance
QACV Consulting

Ty Mew
President
Ofni Systems

Delores Morrison
Director, Validation
Edwards Lifesciences

Miguel Pagan
Senior Compliance Consultant
Agilent Technologies

Paul L. Pluta, PhD
Editor-in-Chief, IVT Network, a division of UBM Americas;
Associate Professor, Biopharmaceutics
University of Illinois at Chicago (UIC)

Jayme Richter
QA Validation Manager
B. Braun Medical Inc.

Lizzandra Rivera
Associate Director, IT Quality
Alexion Pharmaceuticals

Chinmoy Roy
Retiree, Senior Systems Application Engineer
Genentech Inc.

Kristin Shuler
Senior Validation Engineer
Cedarburg Pharmaceuticals, a Division of AMRI

Ivan Soto
Director, Client Engagement and Product Strategy
ValGenesis Systems

Dawn Tavalsky
Senior Director, Global Quality
Sanofi

Kai Wong
Director, Quality LIMS
Kite Pharma

Gamal Amer, PhD
Principal
Premier Compliance Services, Inc.

Michael Barile
Founder and Managing Partner
Barile & Associates, Inc.

Karyn Campbell
Director, Investigations Branch II,
Division of Pharmaceutical Quality Operations I
FDA

Michael Cole
QA Validation Specialist III
B. Braun Medical Inc.

Parsa Famili
President and CEO
Novatek International

Tanya Fletcher-Scott, BS
Chemical Engineering, Director of Quality
Dendreon Pharmaceuticals

Alan Golden, MS
Principal Quality Professional,
Product Quality Operations Support
Abbott Molecular

Roberta Goode, MSBE, CQE
President
Goode Compliance International

Jim Gunning
Director, Quality CSV
Johnson & Johnson

Connie Hetzler
Global Validation Head
Alcon

Lou Killian
Director of Customer Success
Kneat Solutions

Valarie King-Bailey
CEO
OnShore Technology Group, Inc.

Carrie M. Kuehn, MPH, LPD, RAC
Senior Managing Scientist
Exponent, Inc.

Jerry Lanese, PhD
President
The Lanese Group, Inc.

Mohit Malkani
Director of Engineering Services
Bioteknica Inc.

Aida Markham, CQE, CQA
Vice President Compliance
QACV Consulting

Ty Mew
President
Ofni Systems

Delores Morrison
Director, Validation
Edwards Lifesciences

Miguel Pagan
Senior Compliance Consultant
Agilent Technologies

Paul L. Pluta, PhD
Editor-in-Chief, IVT Network, a division of UBM Americas;
Associate Professor, Biopharmaceutics
University of Illinois at Chicago (UIC)

Jayme Richter
QA Validation Manager
B. Braun Medical Inc.

Lizzandra Rivera
Associate Director, IT Quality
Alexion Pharmaceuticals

Chinmoy Roy
Retiree, Senior Systems Application Engineer
Genentech Inc.

Kristin Shuler
Senior Validation Engineer
Cedarburg Pharmaceuticals, a Division of AMRI

Ivan Soto
Director, Client Engagement and Product Strategy
ValGenesis Systems

Dawn Tavalsky
Senior Director, Global Quality
Sanofi

Kai Wong
Director, Quality LIMS
Kite Pharma