Clinical Trial Innovation Summit  
Clinical Trial Oversight Summit
2015 Archived Content

Dinner Short Course*

 Tuesday, June 2, 6:00-8:30 pm

(SC2) Quality by Design in Clinical Research: Is This Only for the Protocol?

Liz Wool, RN, BSN, CCRA, CMT, President and CEO, QD-Quality and Training Solutions, Inc. Biography

In the past few years, Quality by Design (QbD) for clinical trials has been communicated and talked about for protocol development and execution. However, translating this QbD approach into “building in quality for the business,” that is increasingly expected of the industry by regulatory agencies, is rarely shared for the “how do I do this?” because organizations state “I believe we are doing this already.” This workshop will de-code and translate QbD and quality for the research enterprise with examples and interactive activities that will solidify the concepts and framework presented for use within any organization. We will discuss:

• Critical first step: defining quality

• QbD: defined and simplified

• What are QbD and Quality Management Systems (QMS)? How do they relate to each other? How do I know if my organization “has these in place”?

• What are “critical to quality” and “critical control points” in QbD, and why are they important?

• Business practices to QbD principles and methods, and approaches to impart QbD where needed

• Going beyond plans and checklists for quality

• Who is involved and responsible for review?

• Strategies for effective implementation

• Effective training of personnel

*Separate Registration Required