Integrating QbD into Team Science and Project Management for Research Success

The Georgia Clinical & Translational Science Alliance- Georgia CTSA and Southern California Clinical and Translational Science Institute -SC-CTSI have collaborated to provide free, high quality educational programs for clinical research professionals at novice to expert levels of experience. At the completion of each course or program, participants earn contact hours recognized by a certificate and/or badge.

Description:

The experience of a second academic health center’s approach to implementing Quality by Design is presented. Insights on implementation, intricacies of subject matter expert/ stakeholders’ engagement, and the development and outcome of a tailored project plan will be discussed.

Topics:

1. Need for improvement in clinical trial conduct and regulatory submissions
2. The University of Southern California (USC) Solution
   • QbD: A brief history
   • The USC Launch Team
   • QbD Resources
3. Case Study Exercise: Critical to Quality (CTQ) Factor
4. Team Science
5. Project Management Essentials
6. Project Planning: Accrual Projections

Speaker:

Allison Orechwa, PhD supports the development of new programs and services at the Southern California Clinical and Translational Science Institute (SC CTSI) in collaboration with faculty leaders and program staff. Her projects have included the new Clinical Research Support group, University of Southern California’s (USC) research data warehouse, and the implementation science collaboration with UCLA and LA County Department of Health Services. Prior to the SC CTSI, Dr. Orechwa worked as an Education Research Analyst in the Standards and Review Office of the U.S. Department of Education. She earned a PhD from USC in cognitive neuroscience with an emphasis on functional neuroimaging of the brain’s language and reading networks. allison.orechwa@med.usc.edu

Audience:

This program is designed for Clinical Research Coordinators, Project Managers, Monitors, Regulatory, Medical and Clinical Affairs Professionals or junior faculty with 3+ years of experience seeking to further develop clinical research conduct skills and principles.Clinical research professionals should have responsibilities that include clinical trial start up planning, mentoring and complex issues involving site management, study management, and sponsor/ CRO challenges.

Learner Level: Intermediate/ Advanced

Contact Hours:

Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation.Attendees to this CNE activity will be awarded 1.0 Continuing Nursing Education contact hours from ENPDC.

Need Help with Registration? Please contact us at ene@emory.edu or 404-727-9208.

Program Information: This is the third course in a five (5) course program. To complete the entire program and earn a badge CLICK HERE.