Course Description

This interactive two-part, 4-hour web seminar provides participants with the essential skills needed to create effective and actionable audit reports in clinical research settings. Drawing from ICH E6 guidelines and FDA standards, this web seminar will focus on developing clear, concise, and impactful audit documentation that not only identifies compliance issues but also outlines actionable steps for resolution.

Learning Objectives

• Construct factual and objective observations
• Organize information for maximum impact
• Navigate common challenges in report writing and review
• Apply FDA Investigations Operations Manual (IOM) 2024 principles
• Develop practical skills through peer-based exercises
• Implement effective report distribution and response review strategies

Who Should Attend

• Clinical Quality Assurance and Compliance Professionals
• Project Managers
• Regulatory Affairs Specialists
• Clinical Investigators
• IRB Administrators and Members

Instructor

Elizabeth Ronk Nelson, M.P.H.

Click here for complete trainer biographies

Registration Fees

$835*

*Includes up to 20 participants per login at a single location. 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 logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com for pricing.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 4 hours (0.4 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#: 0778-0000-25-024-L99-P. Released: 2/25. 

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