In the "Computerized Systems Validation (CSV)" seminar , you will learn how to validate your computer software quickly and in compliance with the requirements of ISO 13485:2016 and 21 CFR part 820.
goalsThis one-day seminar on validation of computer systems pursues these learning objectives:
- Regulatory requirements
You know the regulatory requirements for the validation of computerized systems, in particular the requirements of ISO 13485:2016, 21 CFR part 820 and part 11.
You can decide which systems require validation and which changes require re-validation. You are aware of the typical problems that occur during audits regarding the CSV. - Best practices
After the seminar you will know which Best Practice Guides (e.g. AAMI TIR 36, IEC 80002-2, GAMP) will help you with the validation of your software systems, and you will be familiar with the interaction with IQ, OQ and PQ. - risk management
You understand how risk management determines the effort for the CSV and how you can minimize the effort for non-critical systems. - validation plan
After this one-day training, you will understand the elements of a validation plan and how the size of the system and the risk of the software or process affect the size of the CSV. You are able to detect and correct errors in a validation plan. - validation and documentation
You know important methods for testing and validation, such as the black box test procedure. After this one-day training, you will have an understanding of which people should be involved in the validation with which tasks and how a lean documentation of the validation results can be achieved.
KONTAKT:
Konstanz - Rheingarten
