Building Quality by Design (QbD) and Risk-Based Quality Management (RBQM) Systems into Clinical Operations

Course Description

The premise behind RBQM is that monitoring quality can be improved by leveraging existing data. The development of quality and risk management metrics involves identifying the values of an organization, and this web seminar will focus on developing measures to assess meeting those goals, building infrastructure to capture data to support the metrics, and establishing adequate and timely responses to drive improvement. As the industry’s utilization of risk-based monitoring continues to increase along with the development and expansion of RBQM, the need for integrating these two concepts is necessary.

Learning Objectives

• Describe the principles of QbD and new regulatory requirements for risk-based monitoring
• Provide an overview of GCP regulations and recent ICH GCP E6 and E8 revisions and their impact on QC/QA process and RBQM systems
• Develop relevant metrics as quality and performance indicators for RBQM systems and effective Corrective and Preventive Action (CAPA) Plans
• Review recent noncompliance trends and regulatory focus for Sites, Sponsors, and IRBs
• Identify and manage risks of clinical trials
• Perform cause-effect analysis for risks and develop mitigation strategies

Who Should Attend

• Clinical Quality Assurance Auditors
• Clinical Quality and Compliance Professionals
• Clinical Research Associates
• Project Managers and Medical Monitors
• Regulatory Affairs Professionals
• Clinical Principal Investigators and Research Coordinators
• IRB Administrators and Members

Instructor

Marina Malikova, Ph.D., MSci, M.A., C.C.R.A., RAC

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#: 0778-0000-21-047-L04-P. Released: 9/21.   

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