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Preparing for PV Inspections – Beyond the Basics

Presenters

Karen  Ward, MS

Karen Ward, MS

Senior Director, Development Quality Assurance, 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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