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#28: 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

    • Senior Director R&D Quality Assurance
    • AbbVie, Inc., United States

    Vicki Burk is the Sr. Director R&D Quality Assurance Clinical QA Program Management, Combination Products and Medical Devices and the Comprehensive Quality Strategy at AbbVie. She leads teams responsible for Clinical QA across all stages of development and Combination Product/Medical Device Design Quality Assurance. 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 Development Life Cycle. Vicki has held several positions at AbbVie in a broad range of quality, technical and operations disciplines.

  • Tim  Grey

    Tim Grey

    • Senior Director,R&D Quality Systems
    • AbbVie, Inc., United States

    Tim Grey joined AbbVie in December 2013. He is currently Senior Director of Research and Development Quality Assurance leading the Quality Systems and Support Services team which includes Quality Systems, Documentation Management, training, QKM, QRM, CAPA, Qualification and Validation activities. Tim has spent his career developing, applying, and implementing quality systems principles across the GxP product development lifecycle. Before joining AbbVie, he was with Eli Lilly and Company in various Quality Assurance positions, including the role of a Lean Six Sigma Black Belt. Early in in his career he had the opportunity to work in the Aerospace industry at Rolls Royce Aerospace where he developed his passion for quality.

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