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Strategies for Quality Management and FDA Compliance

September 26-27, 2017
  • Cambridge, MA

Gamal Amer, PhD
Principal
Premier Compliance Services, Inc.

Marte Cabello
Associate Director, Quality Systems Analytics
Alexion Pharmaceuticals

Alan M. Golden, MS
Principal Quality Professional
Abbott Molecular

Aida Markham, CQE, CQA
Vice President, Compliance
QACV Consulting

Tom Middleton
eQMS Solutions Architect
Sparta Systems

Leslie A. Paul
Associate Director, GCP Audit Services, Falcon Consulting Group, Inc;
former Associate Director, Corporate Quality Compliance, Perrigo

Paul L. Pluta, PhD
Editor-in-Chief, Journal of Validation Technology and
Journal of GXP Compliance, IVT/CBI/UBM;
Associate Professor of Biopharmaceutics
University of Illinois at Chicago (UIC) College of Pharmacy

Isabel Rodriguez, PE, CSQE
President
IRP Consulting, LLC

Brian M. Spencer
Director, Quality Assurance, Lilly Chorus
Eli Lilly and Company

Chris Wubbolt
President
QACV Consulting

Gamal Amer, PhD
Principal
Premier Compliance Services, Inc.

Marte Cabello
Associate Director, Quality Systems Analytics
Alexion Pharmaceuticals

Alan M. Golden, MS
Principal Quality Professional
Abbott Molecular

Aida Markham, CQE, CQA
Vice President, Compliance
QACV Consulting

Tom Middleton
eQMS Solutions Architect
Sparta Systems

Leslie A. Paul
Associate Director, GCP Audit Services, Falcon Consulting Group, Inc;
former Associate Director, Corporate Quality Compliance, Perrigo

Paul L. Pluta, PhD
Editor-in-Chief, Journal of Validation Technology and
Journal of GXP Compliance, IVT/CBI/UBM;
Associate Professor of Biopharmaceutics
University of Illinois at Chicago (UIC) College of Pharmacy

Isabel Rodriguez, PE, CSQE
President
IRP Consulting, LLC

Brian M. Spencer
Director, Quality Assurance, Lilly Chorus
Eli Lilly and Company

Chris Wubbolt
President
QACV Consulting