Good Clinical Practice
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?
The content may also benefit quality managers performing self-inspections.
- 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:
- Cost Effectiveness
For more information please contact EMEA@DIAglobal.org