Risk Management/Risk-Based Quality Management for Clinical Trials Certification Program

Upcoming Courses

Course #: SRBA0819
August 6, 2019
Convene Commerce Square
Philadelphia, PA
Take advantage of our $850.00 price by registering early!
* After July 2, costs are $1,050.00.

Course Description

Are you prepared for Quality Risk Management (QRM), Risk Management (RM), Risk-Based Quality Management (RBQM)? With ICH GCP E6 R2 now requiring risk-based approaches to managing quality in clinical trials, this course takes you through how to execute the requirements in Section 5.0, and reviewing tools while discussing hands-on experience with various risk management programs.

This course focuses on all the critical elements for clinical trial sponsors and CROs included in the ICH GCP E6 R2 expectations, while highlighting key points from other regulatory bodies such as ISO 31000 Risk Management. Further, this course reviews each step of risk identification, assessment, control, review, reporting, management, and communication. Having an effective Risk Management program not only ensures compliance with the ICH GCP E6 R2 requirements but also ensures continuous improvement strategies for your clinical trials.

Learning Objectives

  • Describe the expectations of QRM in relation to the ICH E6 R2 updates
  • Discuss how to analyze risks and develop a risk register
  • Describe how to use multiple risk analysis tools
  • Describe how to formulate risk mitigation strategies

Who Should Attend

  • Quality Control/Assurance Professionals
  • Regulatory Affairs Professionals
  • Clinical Research/Operations Personnel
  • Information Technology/Security Personnel
  • Data Managers
  • Study Managers
  • Project Physicians/Medical Monitors
  • Pharmacovigilance Professionals
  • Biostatisticians     


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

Susan M. Leister, M.B.A., Ph.D., CQA, CSSBB

Click here for complete trainer biographies

Course Outline

Day 1: 8:30 a.m. – 5:00 p.m.

  • Quality Risk Management: Describe Quality Risk Management/Risk Management (ICH GCP E6 R2 & ISO 31000); Discuss establishing a Risk Management Policy/Program and Accountability considerations
  • Risk Management Plan and Culture: Describe the framework for communicating risk within an organization/program; Discuss communication strategies and challenges for risk stakeholders
  • Risk Identification: Describe how to identify risks and when to start; Describe system level risks and project (clinical trial) level risks; Discuss the use of a risk register (risk log) for tracking risks  
  • Risk Evaluation: Describe the likelihood, impact, extent and detection of error; Discuss risk priority number values

Day 2: 8:30 a.m. – 5:00 p.m.  

  • Risk Analysis Tools: SWOT (Strength, Weakness, Opportunities, Threats); Root Cause Analysis and affinity diagrams
  • Risk Control: Discuss developing risk mitigation strategies, options and priority rankings; Discuss internal and external stakeholders and their impact; Describe escalation processes and plans

Day 3: 8:30 a.m. – 5:00 p.m.

  • Risk Communication: Discuss how to document risk mitigation plans in the risk register/log
  • Risk Review: Describe the need for periodic review and when a risk is closed or when it needs further mitigation; Discuss how to detect change and emerging risks (what clinical data to look at)
  • Risk Reporting: Discuss risks, deviations, and predefined quality tolerance limits; Discuss access, retention and the value of lessons learned/continuous learning


Interactive Activities

  • Knowledge Checks
  • Group Discussions
  • Case Studies
  • Group Exercises


Click here for complete hotel information

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 22.5 hours (2.25 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#: 0778-0000-19-047-L01-P. Released: 8/19.


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