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Workshop B: Risk-Based Auditing of Sites
Wednesday September 25, 2024 8:30am - 12:00pm EDT
Gain Insight into Clinical Study Quality by Focusing Site Auditing Efforts to High-Risk Areas 

During this hands-on learning experience, we’ll work through different scenarios to understand how to use audits as a tool to independently evaluate study readiness for inspection, how information from different processes feeds into optimal selection of clinical sites for audit, and the different risk factors that impact that selection.   Perspectives of both QA, Clinical Operations, and Clinical Monitoring are discussed.   

Learning outcomes
    • Understand why and when routine GCP audits should take place and their purpose 
    • Identify the benefits of clinical site audits for overall inspection readiness  
    • Discus how to to identify site-level risk factors (data driven ‘red flags’) 
    • Outline the process of evaluation of risk factors leading to selection of clinical sites for audit 
    • Understand how other factors beyond enrollment impact site selection for the audit 
Speakers
avatar for Anna Borowiecka

Anna Borowiecka

Director, Quality Assurance, Corcept Therapeutics
Anna (M. Sc. Pharm.) is a Quality Assurance professional responsible for auditing, procedures development and supports of ongoing clinical operations in an inspection ready mindset. She started her journey in clinical trials in 2006 as clinical monitor and moved to QA area in 2009... Read More →
avatar for Eliza Gabryjelczyk

Eliza Gabryjelczyk

Director, Evidence Program Management, AstraZeneca
Mature and resilient leader with extensive experience in global clinical operations, recently in Oncology. Collaborative team player and dedicated deliverer. Curious and embracing the change as the only certainty. Passionate for optimization. Aware of own imperfections, nurturing... Read More →
avatar for Adam Rytko

Adam Rytko

Quality Assurance Director, SolasCure
Adam has 19 years experience in clinical trials working for Big Pharma, CRO and Biotechs. Over 14 years in Auditing; leading GCP audits of all major types (Site, Vendor, TMF, Process, Co-monitoring, Documentation, etc.), conducting independent GCP audits worldwide.Currently in charge... Read More →
Wednesday September 25, 2024 8:30am - 12:00pm EDT
  Workshop

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