Workshops are NOT included with Full Conference registration and require a separate fee.

In this interactive 4-hour workshop, participants will explore how an organization’s culture of quality can significantly impact the success of its risk management approaches and outcomes. You will learn how a high-performing culture of quality enhances risk management by supporting robust, proactive processes, while a lower-performing culture can hinder these efforts. Through hands-on activities, real-world case studies, and simulations, participants will gain insights into the practical effects of culture on risk management, from identifying critical risks to implementing mitigation and monitoring strategies. By the end, you’ll leave with a deep understanding of how the culture of quality shapes risk management in clinical trials.

Objectives:

• Understand how a high-performing versus lower-performing culture of quality impacts risk management processes and outcomes.

• Learn to assess Critical to Quality (CTQ) factors, critical processes, and data in clinical trials with consideration of the influence of quality culture.

• Develop skills in conducting risk assessments, including identifying and evaluating risks, and planning mitigation strategies.

• Explore continuous risk monitoring methods and how a culture of quality influences these approaches.

• Apply a maturity model to assess your organization’s current culture of quality and understand its role in shaping risk management decisions.

CEU: 4.00 ACRP

Trainer:

• Leslie Sam, BA, CSSBB, CQIA, President, Leslie Sam and Associates, LLC