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ACRP 2019 OnDemand

162 - Risk Management, the Crash Course

Apr 13, 2019 3:15pm ‐ Apr 13, 2019 5:15pm

Credits: None available.

Non Member: $75.00
Members: $15.00


Are you prepared for the risk management requirements in ICH GCP E6 (R2)? This session will provide a high-level walk through of quality risk management, the key components of a risk management program, and how to conduct a risk assessment at the system and protocol level. We will review the key steps of the process: 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. Practical take-aways will be shared along with sample tools.

Learning Objectives:

  • Define Quality Risk Management (ICH GCP E6 R2 & ISO 31000).
  • Describe the framework for a risk management program.
  • Describe the key steps of risk assessment at the system and protocol level.


  • Susan Leister, BS, MBA, PhD, CQA, CSSBB, Trainer, Barnett International

Credits Available

Risk Management, the Crash Course Exam

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Cynthia Godwin
2/19/20 11:53 pm

Susan did a nice job