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Preparing for PV Inspections – Beyond the Basics

Presenters

Karen  Ward, MS

Karen Ward, MS

Senior Director, R&D QA, Strategic Advice Team, Alexion Astrazeneca Rare Disease, United States

Karen P. Ward, President of Golden Gate Compliance, LLC, provides pharmacovigilance consulting services to a diverse range of clients. Karen previously held compliance and drug safety roles with Coherus BioSciences, Amgen, MedImmune, and Genentech. Karen holds a Master of Science in Jurisprudence from Seton Hall University School of Law, a Bachelor of Arts from DePaul University, and an Associate of Science in Nursing from the West Virginia University Institute of Technology. She is past Chair of the DIA Clinical Safety & Pharmacovigilance Committee, a member of the Society of Quality Assurance, and the Regulatory Affairs Professionals Society.

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