Overview

This course will deliver an in-depth overview of risk-based quality management, including how to assess risk and improve quality within an organisation. As an introduction, general risk management concepts and methodologies will be presented as the basis for Quality Risk Management (QRM) in clinical development and pharmacovigilance. This will be followed by a review of applicable and meaningful metrics for clinical development and pharmacovigilance processes, how these can be best applied, and what change management challenges need to be considered. This is a beginner/intermediate-level course.

What you will learn

General risk management
The latest update on QRM regulations
QRM methodologies such as Failure Mode and Effects Analysis (FMEA)
Key Risk Indicators (KRI) and other tools
Implementation of QRM and change management aspects
Proactive Quality by Design (QbD) aspects

Who should attend?

Clinical study managers
Clinical study monitors
Country study managers
Clinical quality assessment professionals
Compliance and regulatory affairs professionals
Project managers
Risk management officers

Learning objectives

Participants who complete this course should be able to:

Define risk management and how it applies to clinical development
Describe how risk management has been successfully applied in other industries
Demonstrate the basic concepts and requirements for developing and implementing a QRM system
Identify key tools and standards to use in risk management
Evaluate how methodologies such as FMEA can be leveraged when introducing quality risk management in clinical development and pharmacovigilance

Have an account?

Clinical Aspects of Quality Risk Management and Quality by Design

Overview

What you will learn

Who should attend?

Learning objectives

Be informed and stay engaged.