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Speakers

Industry’s Gold-Standard for Validation Excellence

October 17-19, 2017
  • Philadelphia, PA

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

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

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

Karen Ginsbury
CEO
PCI Pharmaceutical Consulting Israel Ltd

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
Alere, Inc.

Lou Killian
Director of Customer Success
Kneat Solutions

Valarie King-Bailey
CEO
OnShore Technology Group, Inc.

Jerry Lanese, PhD
President
The Lanese Group, Inc.

Mohit Malkani
Director of Engineering Services
Bioteknica Inc.

Ty Mew
President
Ofni Systems

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
Senior Manager, IT Quality
Alexion Pharmaceuticals, Inc.

Chinmoy Roy
Retiree, Senior Systems Application Engineer
Genentech Inc.

Naheed Sayeed-Desta
Manager, Process Validation
Apotex, 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

Michael Wolff
Validation Engineer
Tidi Products

Kai Wong
Director, Quality LIMS
Kite Pharma

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

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

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

Karen Ginsbury
CEO
PCI Pharmaceutical Consulting Israel Ltd

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
Alere, Inc.

Lou Killian
Director of Customer Success
Kneat Solutions

Valarie King-Bailey
CEO
OnShore Technology Group, Inc.

Jerry Lanese, PhD
President
The Lanese Group, Inc.

Mohit Malkani
Director of Engineering Services
Bioteknica Inc.

Ty Mew
President
Ofni Systems

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
Senior Manager, IT Quality
Alexion Pharmaceuticals, Inc.

Chinmoy Roy
Retiree, Senior Systems Application Engineer
Genentech Inc.

Naheed Sayeed-Desta
Manager, Process Validation
Apotex, 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

Michael Wolff
Validation Engineer
Tidi Products

Kai Wong
Director, Quality LIMS
Kite Pharma