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Wednesday, April 7 • 10:15am - 11:15am
SENIOR LEADERS PANEL: Culture of Quality

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Driven by the Modernized ICH E8(R1), Organizations Must Be Able to Detect and Monitor Quality Culture: Are You Ready?   
  • Discuss the definition of a culture of quality and the drivers
  • Understand strategies for assessing the health of your quality culture and identify/remediate gaps
  • How do you document an effective culture of quality? 
  • Review lessons learned on how quality cultures were tested during the pandemic 

avatar for Nabil Girgis, MD, CQA

Nabil Girgis, MD, CQA

Senior Director, R&D Quality Assurance, NEKTAR
Clinical quality executive with 28 years of diverse, comprehensive medical and scientific experience across GXP in clinical drug development.  Proven record of accomplishments in implementing successful Inspection Readiness (IR) programs and effective management of regulatory inspections... Read More →
avatar for Dr. Hanna Preus

Dr. Hanna Preus

Global Quality & Compliance Expert, Auditor and Business Strategist with nearly 20 years of versatile operational excellence experience in clinical trial industry across global processes and functions working within Pharmaceutical Companies and Contract Research Organisations across... Read More →
avatar for Sheila Gwizdak, M.S.

Sheila Gwizdak, M.S.

Sheila Gwizdak has over 18 years of experience in the biotechnology and pharmaceutical industry. Her career has focused on quality, process improvement, and training including the execution of corporate and department-level quality assurance initiatives such as SOP development, compliance... Read More →
avatar for David Fryrear

David Fryrear

Executive Vice President, Head of Quality Assurance, ASTELLAS
David Fryrear, M.S., is Executive Vice President and Head of the Quality Assurance for Astellas and has responsibility for providing the global vision, leadership and strategic direction for Quality Assurance, from the earliest stages of research, through clinical development, and... Read More →

Wednesday April 7, 2021 10:15am - 11:15am EDT