GAMP 5 Practitioner Training
Validation of these computerized systems is often difficult and time-consuming, especially when you're not sure how to tackle such validation. A risk-based best practice for validation of computerized systems in a GxP environment, is described in the ISPE GAMP® 5 Guide: 'Compliant GxP Computerized Systems'.
Based on this guide, a GAMP 5 Practitioner training has been developed to help course participants understand what is expected according to the guide and the regulations when validating computerized systems. During the training, the theory from the ISPE GAMP® 5 Guide, combined with the practical experience of the trainer(s), is translated into a process-focused and risk-based approach for the validation of computer systems.
The training will continuously switch between presentation of the theory and applying this theory to a practical case. All presentation material is in English
Amongst others, the following topics will be discussed:
- What are computerized systems
- What is the lifecycle of a computerized system and what is the impact of being compliant
- How do requirements follow from processes
- How can requirements be set up in a SMART way
- How can requirements be tested
- How do processes help in executing a risk assessment
- How do risk management and risk assessment help to reduce the workload of validation
- What do different development methods, like Agile, mean to validation deliverables
- Which environments of systems are used, why are they used, and what are they used for
- Which processes need to be covered during Computerized System Operation
- In what detail should documentation be developed