The Future of Clinical Trial Conduct Demands a Quality System Approach: Will You Be Ready?

Course #: SQSA0618
June 6-7, 2018 | Philadelphia, PA
8:30 AM - 5:00 PM Eastern
Convene CityView Take advantage of our $1675.00 price by registering early!
* After Friday, May 4, 2018, costs are $1875.00.
Take advantage of our $1675.00 price by registering early!
* After Friday, May 4, 2018, costs are $1875.00.

Course Description

The future of clinical trial conduct demands a Quality System approach. Recently, regulators have been recommending that a quality system approach be used for the design, development, and execution of clinical studies. FDA guidances speak on the need to conduct clinical trials using such an approach, but provide little in the way of direction on how to accomplish this. Risk management is an integral component of a quality system approach, and many researchers do not have the knowledge or experience to conduct clinical trial risk management. This course will apply practical approaches and demonstrate associated tools and skills to assist the participant in using a quality system approach within the clinical trial arena from both the site and sponsor perspective.

Learning Objectives

  • Identify regulatory body/authority recommendations for a quality system
  • Describe a quality system approach as it pertains to trial conduct
  • Apply the concepts of a risk management approach and how they relate to a quality system approach
  • Describe how corrective and preventive action (CAPA) and root cause analysis (RCA) pertain to a quality system approach
  • Define and demonstrate the application of quality system approach tools to study conduct

Who Should Attend

  • Clinical Quality Assurance Professionals
  • Clinical Operations Personnel
  • Investigators and Sub-Investigators
  • Study Coordinators
  • Study Monitors
  • Project Managers


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

Lee Truax-Bellows, M.S., FNP, C.C.R.A., RQAP-GCP

Click here for complete trainer biographies

Course Outline

Day One: 8:30 a.m. – 5:00 p.m.

  • Principals of Quality Management System (QMS)
  • Fitting Clinical into the QMS  
  • Developing a QMS Quality Manual Group Exercise  
  • Principals of Risk Management  
  • Risk Management Group Exercise  

Day Two: 8:30 a.m. – 5:00 p.m.

  • Recap Day One
  • Principals of RCA  
  • RCA Group Exercise  
  • Principals of a CAPA Program  
  • CAPA Group Exercise
  • Questions and Answers

Interactive Activities

  • Group Breakout Exercises
  • Q&A

Registration Fees

Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.

Special rates are available for multiple attendees from the same organization.  Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.  

Click here for our seminar cancellation policy

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 15 hours (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#: 0778-0000-18-008-L01-P. Released: 2/18.


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