Is your institution faced with an audit/inspection and you want to prepare the team? If so, then this course is ideal for you. We will show you what to do before, during and after the actual audit/inspection and how to respond to the audit/inspection report.
This 1-day course is designed to provide a basic understanding of the audit or inspection preparation in clinical drug development (except medical devices) and will demonstrate the importance to ensuring good data quality, as a basis of successful audit outcome.
Audits and inspections are a fact of life when running clinical trials. This course will provide delegates with advice on the differences between audits and inspections, preparing and providing information to audits/inspections, workshops to improve communication and advice on how sites respond to audit/inspection findings.
Course time09h00 - 17h00
Who should attend
This course is designed for clinical research professionals who are faced with an audit or inspection. Quality and project managers who have to guide their team through the audit and wanting to know what to do before, during and after an inspection or audit.
- Assign the right persons for the audit/inspection stage and support
- Prepare the documentation
- Prepare the team
- How to present non-compliances occurred during trial conduct
- Technical hints and tips for right behaviour.
- Understand how audits and inspections are conducted
- Get hands-on information about how to prepare the team and documentation for a smooth audit/inspection
- Get an overview of applicable standards
- Know the data and document requirements specific to audits/inspections
- Know how to prepare for sponsor/CRO and sites audits/inspections
- Recognise continuous high-quality standards as a method of ensuring data quality
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (0)
- Ethical & Participants Safety Considerations (0)
- Investigational Product Development and Regulation (2)
- Clinical Studies Operations (GCPs or ISO 14155) (3)
- Study and Site Management (1)
- Data Management and Informatics (2)
- Leadership and Professionalism (0)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained