Course Description

Over the past few years, Quality by Design (QbD) for clinical trials has been a focus for protocol development and execution. However, even though it is increasingly expected of the industry by regulatory agencies, translating this QbD approach into EEbuilding in "lity for the businessEE is rarely shared for the EEhow do I do this?EE This web seminar will de-code and translate QbD and quality for the research enterprise with examples that will solidify the concepts and framework presented for use within any organization. We will discuss the critical first step of defining quality; how to simplify QbD; how QbD and Quality Management Systems (QMS) relate to each other; determining whether your organization has these in place; what the best QbD principles and methods are; how to go beyond plans and create checklists for quality; and, finally, strategies for effective implementation.

Case Study: QbD for a CRA Study Management Plan

Job Aid: QbD Worksheet

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Learning Objectives

• Differentiate QbD and QMS in clinical research
• Determine if your organizationEEs practices reflect elements of a QMS and QbD principles and methods
• Identify QbD practices to utilize in the functional area and/or business enterprise

Who Should Attend

• Clinical Operations Professionals
• Project Managers
• Quality Ass