Speaker: Dr Lydie Moreau
Training Objectives
- Dive into the main standard, key theoretical aspects and methodologies for risk management
- Use the main risk management tools (PHA, FMEA)
- Build a risk analysis through the example of a medical device
- Know how to build a risk management file together with the SOP on risk management
Training Content
- Overview of theoretical aspects of risk management
- Exercise: Filling a PHA for a medical device example; discussion around IVD specificities
- Theory on FMEA methodology
- Exercise: Filling the risk analysis matrix using the FMEA methodology for a medical device example; discussion around IVD specificities
- Theory on risk acceptance criteria and mitigation measures
- Exercise: Completing the risk analysis matrix with mitigation measures for the medical device example
- SOP and Risk management file (plan/ report)
Training Format
- Presentations with interactive discussions through several exercises
- End of training assessment
Price
EUR 625 incl. course material and certificate