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

Please check back later for this seminar's current schedule, or review our other live seminars for similar courses.

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.

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


Christina Eberhart, B.S. 

Click here for complete trainer biographies 

Registration Fees


Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-14-079-L01-P. Released: 9/14. 

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