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3rd Clinical Quality Oversight
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Wednesday, May 22 • 2:30pm - 3:00pm
ASSESS VENDOR RISK

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Apply A Risk-Based Methodology to Vendor Qualification and Ongoing Performance Assessments to Optimize Resources and Ensure Compliance
  • Discuss a risk-based approach to categorizing active vendors for initial and ongoing qualification 
  • Factoring in the study’s CTQs to develop a risk-based and scalable vendor qualification process 
  • Identify risk-control parameters to help mitigate delays in the qualification process and beyond
  • Discuss effective strategies for conducting continuous risk assessments of vendor performance 
  • Share how to handle high-risk observations that can impact future selection and qualification
Speakers
avatar for Sharon Reinhard

Sharon Reinhard

Clinical Quality Expert, Independent Consultant
Experienced pharmaceutical executive with 25 years of industry experience, including roots in academia. Most recently Head of Commercial and R&D Quality at AVEO Oncology.  Prior to that, Vice President/ Head of Quality at AVROBIO, a gene therapy company focused on lysosomal storage... Read More →

Wednesday May 22, 2024 2:30pm - 3:00pm EDT
  IN-PERSON Experience ONLY