Are you faced with an inspection from FDA, EMA or local authority and you want to prepare yourself and your team? We will show you what to do before, during and after the actual inspection and how to respond to the inspection report.
This one day course is designed to provide a basic understanding of the inspection process in clinical drug development (except medical devices) and will demonstrate the importance to ensuring good data quality, as a basis of successful inspection outcome. Inspections are a fact of life when running clinical trials. This course will provide delegates with information about how inspections are conducted, advice on preparing for inspections and providing information to inspectors, a summary of common inspection findings and advice on responding to inspection findings.
Course time09h00 - 17h00
Who should attend
This course is designed for clinical research professionals who are faced with an authority inspection. Quality and project managers who have to guide their team through an EMA or FDA inspection and wanting to know what to do before, during and after an inspection.
- Assign the right persons for the 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 inspections are conducted
- Get hands-on information about how to prepare the team and documentation for a smooth inspection
- Get an overview of applicable inspection standards
- Know the data and document requirements specific to inspections
- Know how to prepare for sponsor/CRO and sites inspections
- Recognise continuous high quality standards as a method of ensuring data quality