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Research Site Quality Compliance Programs: Review of Industry Gold Standards
Session Chair(s)
Liz Wool, BSN
President
Wool Consulting Group Inc., United States
This workshop provides a review with examples of site quality compliance frameworks and programs. Additionally, this workshop reviews the risk management strategies for sites to use when launching or augmenting their quality compliance framework.
**Due to workshop format, seating will be limited and will be available on a first come, first served basis.
The San Diego Convention Center has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive at workshops early in order to ensure seating. Please note, as a workshop with interactivity, this offering will not be recorded.
Learning Objective : Describe the core elements of a site quality program;Define key risk parameters to be monitored that support site quality; Determine short- and long-term strategies for implementation and augmentation of the site quality program.
Speaker(s)
Core Elements: Site Quality Compliance Framework
Christine Pierre, RN
Society for Clinical Research Sites, United States
President
Building Quality by Design (QbD) and Quality Risk Management (QRM) Systems into Clinical Site Operations
Marina Alexandra Malikova, PhD, MBA, MS, RAC
Boston University School of Medicine, United States
Executive Director, Translational Research, Assistant Professor of Surgery
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