Course Description

This two-part, comprehensive 4-hour web seminar equips clinical research professionals with essential skills for responding to audits and developing effective Corrective and Preventive Action (CAPA) plans. Participants will learn how to critically assess audit observations and craft robust responses. Best practices for root cause analysis, CAPA development, and implementation to address audit observations will be discussed. Through case studies and practical exercises, learners will also gain confidence in navigating the audit response process and enhancing their organization’s quality management systems.

Learning Objectives

• Assess audit observations and discern the true focus of observations
• Utilize root cause analysis techniques to identify underlying issues in audits
• Develop strategies for effective preparation, assessment, and implementation of CAPA plans and ensure efficacy
• Enhance CAPA systems to ensure compliance and improve quality management practices

Who Should Attend

• Quality Assurance Professionals
• Principal Investigators
• IRB Chairs and Administrators
• Clinical Operations Professionals

Instructor

Elizabeth Ronk Nelson, M.P.H.

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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#: 0778-0000-25-022-L99-P. Released: 1/25. 

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