Course Description

An audit is defined as a systematic and independent examination of trial-related activities and documents. Beyond the review of documents and interviews, auditors are tasked with using factual, objective evidence to support conclusions regarding compliance and assessing whether proposed interventions are acceptable to effectively address the underlying concerns. Utilizing real-life examples and information, participants will work individually and within a group of their peers to review material, assess significance of findings, determine whether or not compliance issues exist, and develop plans for efficient compliance solutions. This interactive web seminar will allow participants to further develop auditing skills.

Learning Objectives

• Discuss current Good Clinical Practice (GCP) compliance issues
• Assess patterns in data using data trend analysis
• Review information for accuracy and validity
• Perform root cause analysis for a study scenario and develop a corrective and preventive action plan (CAPA), including impact assessment to facilitate review of intervention

Who Should Attend

• Clinical Quality Assurance Professionals
• Auditors
• Project Managers
• Clinical Investigators
• Clinical Operations Professionals
• Personnel responsible for ensuring compliance with Good Clinical Practice (GCP) regulations

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 3 hours (0.3 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#: 0778-0000-25-001-L99-P. Released: 1/25. 

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