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Training Courses - Web Seminars
A Barnett Interactive Web Seminar offers you a seamless, secure, multimedia learning experience. These live, instructor-led sessions are designed to be highly interactive, and can be attended by individual attendees or groups at one low cost. No travel, no travel expenses, and no time away from the office!

Risk-Based Auditing: Effective Compliance Strategies

Upcoming Courses

Course #: BI16168
June 25, 2024 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
Course #: BI16315
September 5, 2024 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
Course #: BI16428
December 6, 2024 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern

Course Description

An audit is defined as a systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, the sponsor’s standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s). Auditing focuses on the systems that generate this data, whereas monitoring tends to focus primarily on the data. Risk-based approaches to auditing, such as focusing on the most critical data elements, are more likely to ensure subject protection and overall study quality, and will permit sponsors to focus their compliance efforts more effectively. This web seminar will provide an overview of risk-based auditing skills and techniques, and a review of recent GCP audit findings from Clinical Investigators (sites), sponsors, and Institutional Review Boards (IRBs).

Learning Objectives

  • Review similarities and differences in risk-based auditing and monitoring
  • Examine the structure of the quality assurance/quality control relationship
  • Apply risk assessment and management principles to clinical quality assurance
  • Review elements of risk-based auditing and compare to traditional auditing practices
  • Discuss how the timing of the audit impacts risk assessment and control
  • Evaluate recent noncompliance trends and regulatory focus for sites, sponsors/CROs/monitors, and IRBs

Who Should Attend

  • Clinical Quality Assurance Auditors
  • Clinical Quality and Compliance Professionals
  • Clinical Research Associates
  • Project Managers
  • Sponsor Investigators


Elizabeth Ronk Nelson, M.P.H.

Click here for complete trainer biographies

Registration Fees


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: 

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 2 hours (0.2 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#: 0778-0000-23-066-L99-P. Released: 9/23. 

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