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

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 “building in quality for the business” is rarely shared for the “how do I do this?” 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

Learning Objectives

• Differentiate QbD and QMS in clinical research
• Determine if your organization’s 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 Assurance and Compliance Personnel
• Business Process Owners
• Risk Management Specialists

Instructor

Liz Wool, R.N., B.S.N., C.C.R.A., CID, CMT

Click here for complete trainer biographies

Registration Fees

$735

Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: customer.service@barnettinternational.com 

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-15-072-L01-P. Released: 8/15. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.