Quality and Process Improvement Techniques and Tools
Course Description
Proper investigation of issues identifying the root cause is critical to the long-term success of a clinical trial. Using the correct quality tools and techniques is essential to ensure the problems are fully understood, investigated, and resolved. This interactive course is designed for quality staff and clinical staff who work seek to better understand how to select and utilize various tools to investigate risks and proactively mitigate them.
The workshop will include hands-on experience using various quality tools and techniques while discussing case studies in clinical trials.
Throughout the course we will:
· Investigate the root cause of typical clinical trial issues and risks proactively
· Establish proper mitigation/solutions reflective of acceptable long-term plans that regulatory authorities expect
· Review and utilize process improvement techniques with various challenges in clinical trials
· Review how to streamline processes frequently used in clinical trials and discuss typical challenges.
Upon completion of this course, you will have the knowledge and skills to utilize multiple quality tools and techniques to uncover the root cause of critical risks within your clinical trials and be able to properly document the investigation and resolution of those challenges. In addition, we will review other process improvement techniques and streamlining other documented processes frequently used in clinical trials.
Learning Objectives
By the end of this course, participants will be able to:
· Describe various quality tools and techniques to use for root cause analysis and process improvement in clinical trials
· Apply various quality tools and techniques and understand when to use them
· Identify and document issues/risks early on and utilize various tools and techniques to properly investigate them
· Develop and implement effective process improvement strategies for clinical trials in different situations to demonstrate oversight
Who Should Attend
This course is ideal for:
· Quality assurance and quality control staff involved in clinical research; Clinical trial staff and clinical project managers or other service providers
· Anyone involved in clinical trial delivery seeking practical quality tools to better understand process improvement and root cause analysis
Instructor
Susan M. Leister, MBA, PhD, CQA, CSSB
Click here for complete trainer biographies
Registration Fees
This course will be held immediately following SCOPE 2026 in Orlando, FL at the Rosen Shingle Creek. Please click here to book your hotel room and receive the special SCOPE rate.
Special rates are available for multiple attendees from the same organization or if you are planning to attend SCOPE. Please contact Barnett Customer Service at +1 215.413.2471 or toll-free in the U.S. 800.856.2556 for more information. Or email Customer Service at: customer.service@barnettinternational.com.
Accreditation Information
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 9 hours (.9 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#: 0778-0000-25-057-L99-P. Released: 10/25.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.
