Content
Computer system validation (CSV) is a methodical approach to analyze and test computer-based systems in development, production or testing that influence the quality of the product. This is to ensure that they work as intended and that there is no increased risk. In addition to the FDA in 21 CFR Part 820.70, DIN EN ISO 13485 now also requires this very explicitly in several chapters.
Topic overview
- Overview and reference to DIN EN ISO 13485 and the CFR
- Terminology and overview of GAMP 5 as the most important guideline for CSV
- Course of a validation project from the beginning to the released process using the V model
- Explanation and procedure for the individual stages of validation
- Essential content of an SOP and associated forms for carrying out a CSV
- Practical relevance as an aid to concrete implementation
target group
Employees from development, production, quality assurance and IT.
Prior knowledge
Not required.
Funding opportunity
ESF funding is possible. Further information can be viewed here .
Early bird discount
If you register up to 3 weeks before the start of the seminar, you will receive an early bird discount of 10 percent.
KONTAKT:
TuttlingenTuttlingen & Online
