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Wednesday, September 29 • 10:45am - 11:45am
TRACK A PANEL: Documenting Oversight

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Understand What Documentation Is Needed to Showcase Oversight to Inspectors 
  • Update on regulatory requirements for documenting oversight
  • Evaluate different company’s processes for documenting oversight of vendors and sites
  • Discuss experiences with regulators requesting or questioning oversight documentation
  • Recommend best practices for documenting oversight

avatar for Eileen DiRita

Eileen DiRita

Associate Director, Quality Systems, CSL BEHRING
avatar for Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP

Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP

Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC
Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP is an accomplished clinical quality and regulatory compliance professional with in-depth knowledge of all facets of clinical trial operations and the ability to support management and clinical teams that are conducting compliant clinical... Read More →
avatar for Dawn Lundin

Dawn Lundin

Dawn Lundin has over 24 years of GxP experience from quality assurance and compliance roles in both industry and academia. Versed in the Common Rule and clinical development regulations, currently head of compliance for the Perelman School of Medicine and Director of the Quality Assurance... Read More →
avatar for Michele Weitz

Michele Weitz

Senior Director, Clinical Standards and Innovation, CLOVIS ONCOLOGY
A pragmatist on a mission to make clinical trial regulatory requirements meaningful and accessible to a tough crowd, Michele has worked as both an employee and consultant at pharmaceutical companies of all sizes—from 23 to 111,000 employees, in many therapeutic areas and around... Read More →

Wednesday September 29, 2021 10:45am - 11:45am EDT