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

In today’s fast-evolving clinical trial landscape, empowering a culture of quality is the key to driving success and ensuring compliance with evolving global standards, including those described in ICH E6(R3). This interactive half-day workshop will focus on practical strategies and tactics for creating, influencing, and sustaining a high-performing culture of quality. Participants will explore key elements like proactive risk management, leadership engagement, and continuous improvement through interactive activities, real-world examples, and collaborative exercises, you will learn how to foster a mindset of quality (beyond compliance) that leads to better trials and improved outcomes, all while aligning with the latest regulatory expectations. Whether you’re shaping a new quality culture or strengthening an existing one, this workshop will equip you with the tools to make quality the cornerstone of your clinical research operations. 

Objectives:

• Understand the Foundations of a Quality Culture: Define what a high-performing culture of quality looks like in clinical trials. 

• Recognize the Signs of a Failing Quality Culture: Identify the common signs of a struggling or failing culture of quality and understand how this impacts trial success. 

• Learn How to Shape and Influence a Culture of Quality: Discover strategies to influence, turn around, and sustain a culture of quality at both investigator sites and sponsor organizations. 

• Measure and Monitor Quality Culture: Learn how to effectively measure and monitor an organization's culture of quality using qualitative and quantitative tools. 

• Collaborate to Develop a Quality Action Plan: Work with peers to create actionable plans for improving or sustaining a culture of quality in your own organization. 

CEU: 4.00 ACRP

Trainer:

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