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#23: R&D QA Comprehensive Quality Strategy: An Approach to Managing Quality Risks Throughout the Drug Development Lifecycle


Instructors

  • Kevin  Grebner

    Kevin Grebner

    • Director, Clinical Quality Assurance
    • AbbVie, Inc., United States

    Kevin Grebner is a director in R&D Quality Assurance at AbbVie. Kevin leads the Program Management team responsible for developing and managing the Clinical QA strategy in support of compounds throughout the development life cycle. In his 32 year career at Abbott/AbbVie, Kevin has held various positions in a variety of organizations including Clinical Development, Clinical Outsourcing, and Drug Discovery. Kevin has a B.S. in Chemistry from Northern Illinois University.

  • Victoria  Burk

    Victoria Burk

    • Director R&D Quality Assurance
    • Abbvie, United States

    Vicki Burk is the R&D Quality Assurance director of Combination Products and Medical Devices at AbbVie. She leads a team responsible for Design Quality Assurance and the R&D Combination Product and Device Quality System. Vicki is also the business process owner for the R&D Comprehensive Quality Strategy, a cross-GxP framework used to manage Quality Risks Throughout the Drug Development Life Cycle. Vick has held several positions at AbbVie in a broad range of quality, technical and operations disciplines including Quality Assurance, Supplier Quality, Manufacturing and Post-Market technical support. Vicki has a B.S. in Chemistry from the University of Notre Dame.

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