Training Seminar - 2025 Archive

2025 ARCHIVES

Thursday, February 6, 2025 2:00 - 5:00 pm | Friday, February 7, 2025 9:00 am - 4:30 pm

TS1: Risk-Based Quality Management for Clinical Trials: Implementing ICH E6 R3 Requirements

Course Description:
Are you prepared for Quality Risk Management (QRM), Risk Management (RM), and Risk-Based Quality Management (RBQM)? With ICH GCP E6 R3 in the final stage, the guideline still requires risk-based approaches to managing quality in clinical trials, and this 1.5-day course takes you through—step-by-step—how to execute these requirements. We will focus on the critical elements for clinical trial sponsors and CROs included in the ICH GCP E6 R3 expectations while highlighting key points from other regulatory bodies such as ISO 31000 Risk Management. Each step of risk identification, assessment, control, review, reporting, management, and communication are also reviewed, along with what is to be documented in the clinical study report.

Susan M. Leister, MBA, PhD, CQA, CSSBB, Vice President, Quality & Compliance, Technical Resources International, Inc.; Senior Trainer, Barnett International

Learning Objectives:

Describe the expectations of QRM in relation to ICH E6
Discuss how to analyze risks and develop a risk register
Describe how to use multiple risk analysis tools including: Failure Mode Effect Analysis (FMEA), Bow Tie, and Affinity Diagram
Describe how to formulate risk mitigation strategies

Course Outline:

Module 1: Quality Risk Management: Risk Management in Clinical Trials and Regulatory Requirements in ICH E6 R2
Module 2: Defining Risk and Risk Identification: Risk Identification and When to Start, System Level Risks and Project (Clinical Trial) Level Risks, Risk Register (Risk Log) for Tracking Risks
Module 3: Risk Evaluation: Impact of Error, Detection of the Error, Risk Priority Number (RPN) Values
Module 4: Risk Analysis Tools Part I: FMEA, Bow Tie, and Delphi technique, SWOT (Strengths, Weaknesses, Opportunities, Threats), Affinity Diagram, Cause and Effect Analysis
Module 5: Risk Control: Risk Mitigation Strategies, Risk Mitigation Options, Priority Rankings of Risk Mitigation Plans
Module 6: Risk Communication: Risk Mitigation Plans in the Risk Register/Log, Impact of Internal and External Stakeholders, Escalation Processes and Plans
Module 7: Risk Review: Periodic Review, Risk Assessment, and Risk Detection
Module 8: Risk Reporting: Risks, Deviations, Predefined Quality Tolerance Limits, Lessons Learned/Continuous Learning, S/Logs

Day 1 Agenda:

1:30–2:00 pm Training Seminar Registration

2:00 Welcome, Introductions, and Review of Course Objectives

3:30 Refreshment Break

3:45 Course Resumes

5:00 Close of Day 1

Day 2 Agenda:

9:00 am Training Seminar Resumes

10:30 Refreshment Break

12:00 pm Break for Lunch

1:00 Training Seminar Resumes

2:45 Refreshment Break

3:00 Course Resumes

4:30 End of Training Seminar

INSTRUCTOR BIOGRAPHIES:

Susan M. Leister, MBA, PhD, CQA, CSSBB, has over 20 years of experience covering the pharmaceutical, medical device, and clinical arena, including extensive working knowledge of GCP, cGMP, GLP, ICH E6 GCP, and HSP. She has managed various inspections including ISO, CE Mark, Health Canada, MHRA, EMA, DEA, Maryland Board of Pharmacy, and FDA. Dr. Leister provides QM oversight to multiple government and commercial clients from large pharma to the small biotech startup. She currently oversees a QA auditing team comprised of ~ 20 FTEs who verify monitoring performance and internal audits with a global reach, conduct quality trend analysis including analysis of reports and associated data, and provides recommendations and quality consultative services. She is experienced in managing NIH drug repository and stability lab for domestic and international clinical trials and is skilled in developing plans for resolutions to deviations and CAPAs, analyzing QA/QC results, and recommending process improvements with 6 Σ. Dr. Leister is seasoned in mock inspections and overall inspection readiness.

About Barnett International:
Barnett International is a leader in training and resources for clinical research professionals. The Barnett approach is unique in that it combines content development expertise with a high level of subject matter experience, engaging instructional design and a multi-platform approach. Our education and training portfolio offers diverse options for all types of learners. Barnett helps clients get the most out of their research and development dollars by managing change effectively, improving organizational performance, and enhancing staff knowledge. The "Barnett Difference" is evident in our deep understanding of the clinical research process and in the rapid and tangible performance improvements we deliver.