In this seminar, you will learn how to validate your computerized systems (e.g., ERP, compilers, or self-developed EOL testers) in a risk-based, fast, and regulatory-compliant manner and how to create the necessary documents so that you can face future audits without worries.
You will first learn about the regulatory requirements of ISO 13485:2016 and 21 CFR part 820 for validating computerized systems. We will then illustrate the implementation of proposals from various guidance documents to meet these requirements using a sample ISO/TR 80002-2-based CSV process, which you can adopt directly into your quality system after the seminar.
After the seminar, you will know exactly
Our expert will show you how to apply CSV during the seminar using concrete validation documents from projects that have already been implemented. You will also benefit from valuable tips and learn which typical problems occur during audits and how to avoid them.
You can find the exact learning content as well as the schedule of the seminar in the agenda: