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

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.

Training seminar delivered by:

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