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Developing Quality by Design (QbD) Tools for Clinical Researchers

1 credit


Full course description

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.


This course presents the experience of an academic health center’s implementation of Quality by Design (QbD), including creation of the QbD working group, application of QbD principles on selected clinical trials in a 2-year pilot project, and collaborative efforts for national level QbD implementation.


  1. Background
  2. Challenge: Crisis of Trust in Clinical Research
  3. Solution: Quality by Design
    • Theory to Practice
    • ‘Critical to Quality Factors’ (CTQ)
  4. QbD Adoption and Implementation: Local Level
    • Academic Health Centers
    • University of California Irvine QbD Workshop
  5. QbD Implementation: National Level
    • CTSA Collaborative Innovation Award
      • Specific Aims
      • Expected Outcomes/Impact


Hamid Moradi, MD, is an Associate Director of the Nephrology Fellowship Program, Medicine; School of Medicine, Associate Clinical Professor, Division of Nephrology, Hypertension & Kidney Transplantation at the University of California, Irvine. Dr. Hamid Moradi is a nephrologist in Orange, CA and is affiliated with multiple hospitals in the area, including UC Irvine Medical Center and VA Long Beach Healthcare System. He received his medical degree from Oregon Health & Science University School of Medicine and has been in practice 15 years. He specializes in acute kidney injury, chronic kidney disease and dialysis, and glomerular disease. His research emphasis is on deciphering novel pathways which can be targeted to improve survival in end stage kidney disease (ESKD) by looking at lipids, lipid metabolism and alterations of the endocannabinoid system in advanced chronic kidney disease.


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 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.

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