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3rd Clinical Quality Oversight
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Thursday, May 23 • 9:45am - 10:30am
ROUNDTABLE DISCUSSIONS

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Each conference participant selects one topic from the following list to discuss in an intimate setting.  You’ll be asked for your topic preferences via email a week or so out from the conference and sign-up sheets for the remaining slots will be available onsite.
  • WHAT MAKES A QUALITY CULTURE?  Discuss the Cultural Tenets Needed to Embrace Transparency and Fuel a Quality-First Mindset
  • GLOBAL QUALITY CULTURE: Share Experiences on Transforming Quality Culture in a Global Organization where Cultural Norms are Quite Different
  • EFFECTIVENESS CHECKS:  Manage Issue Resolution to Mitigate Risk by Preventing Future Occurrences
  • QUALITY BY DESIGN: Understand the Concept of Quality By Design as it Relates to Vendor Oversight and how Build Quality into the Partnership to Ensure Compliance
  • CLINICAL DATA INTEGRITY: Share Common Data Integrity Challenges and Oversight Strategies to Mitigate Them  
  • STORYBOARDS: Understand How Companies are Using Storyboards to Document Oversight
  • OVERSIGHT AT SMALL COMPANIES:  Engage with Other Small Companies on How to Execute Effective Oversight with Limited Resources
  • CHANGE MANAGEMENT: Share Best Practices for Handling and Managing Change without Impacting Clinical Quality Oversight
  • OVERSIGHT RESPONSIBILITY AND DOCUMENTATION:  Discuss Varying Approaches for Assigning who Owns, Manages and Documents the Oversight Process to Evaluate the Best Fit for Your Company
  • QUALITY AGREEMENTS: Discuss the Utility of a Quality Agreement and How it Relates to Other Documentation
  • MOCK INSPECTIONS:  Evaluate Varying Approaches for Leveraging Mock Inspections as an Oversight Tool


Thursday May 23, 2024 9:45am - 10:30am EDT