Overview

This practical clinical trial audit course is an opportunity to share experiences and develop skills in the methods and approaches to planning, conducting and reporting different types of audits.

With targeted discussions on regulatory hot topics, common challenges, audit trends and updates in clinical trial legislation and guidance, this course is a combination of presentations and discussions, and workshop exercises facilitated by an experienced team of auditors.

What you will learn

Risk-based approach to audit planning and conduct
Quality management, Quality Control and Quality Assurance
Trial audits in practice
System audits in practice
Regulatory framework EU and ICH
Communication of audit findings
Inspections by European and other authorities
Evaluation of Corrective and Preventative Action Plans

Who should attend?

This course is designed to provide practical training to conduct audits for regulatory authority inspectors, auditors, monitors, professionals preparing for an audit or inspection and clinical trial coordinators in a quality role at health institutions.

The content may also benefit quality managers performing self-inspections.

Learning objectives

At the conclusion of this course, participants will be able to:

Develop and apply a risk based approach for the planning and conducting audits
Use common audit methodology principles when conducting audits
Report on trial specific and system audits
Report and provide value-added feedback to ensure robust corrective and preventative action plans
Understand activities to be performed to ensure inspection readiness

Participants will complete a knowledge check at the end of the course and will be provided with feedback to ensure learning objectives are attained.

Plan Your Team's Professional Development

Why not take advantage and train your whole department (or even across different departments!) and benefit from increased:

Focus
Flexibility
Convenience
Cost Effectiveness

For more information please contact EMEA@DIAglobal.org

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