Quality by Design: A Lean Six Sigma Approach to Risk-Based Monitoring March 2015

Mar 24, 2015
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Course Description

Monitoring consumes 30-60% of an operational budget for clinical trials or clinical programs. To sustain growth and reinvest in innovation, sponsors must find viable alternatives to reduce the resource burn, as well as create efficient and effective solutions to increase regulatory compliance, data integrity, and patient safety. By utilizing the combined toolboxes of Lean Six Sigma (LSS) + Quality by Design (QbD), sponsors can continue to invest in innovative products while producing customer-centric/efficient operational processes that are highly adaptable, constantly reproducible, and consume fewer resources. LSS + QbD provides CRAs and other risk-based monitoring staff with an arsenal of analytical tools to conduct fewer on site monitoring visits yet monitor the site more effectively and in real-time.

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Learning Objectives

  • Review the current regulatory environment and identify internal and external risks in clinical trials, at sites and with the sponsor
  • Define the Quality by Design (QbD) step-by-step method for implementing risk-based monitoring
  • Identify Lean Six Sigma tools (LSS) to mitigate, monitor, and control risk in a clinical trial

Who Should Attend

  • Clinical Research Associates
  • Clinical Research Associate Managers
  • Sponsor Certified Quality Auditors
  • Clinical Development/Operations Managers/Directors
  • Site Quality Compliance Monitors
  • Site Quality Assurance Auditors


The course will be led by one of the following instructors:

Christina Eberhart, B.S.

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.