Learn the fundamentals for successful validation of software and computerized systems in the GxP environment in our seminar.

The increasing digitization and automation in regulated environments pose complex challenges for companies. Computer System Validation (CSV) is a central component of modern quality assurance and regulatory compliance.

Brief description:

In addition to complying with legal requirements, computer-assisted systems must operate reliably, securely, and traceably — especially in the GxP environment. This requires an overview of the key requirements for validation and operation of computerized systems in the GxP setting.

In our seminar on the fundamentals of computer system validation, we will teach you the essential principles, terms, and methods of CSV. The goal is to develop a solid understanding of the requirements from GAMP® 5, the EU-GMP Guide (Annex 11), as well as relevant standards such as ISO 13485 and 21 CFR Part 11.

The seminar concludes with a certificate of participation.

Target audience:

The seminar is aimed at employees from the pharmaceutical and medical technology industries, as well as manufacturers or suppliers of computerized products who want to gain an overview of their customers' requirements. The seminar can also be helpful for areas that need to implement customer or validation requirements (e.g., GDP, suppliers for GMP).

Our seminar instructor:

We offer you the best possible service through our many years of experience. Each individual is an expert in their field and shares their technical knowledge and experience in our seminars.

Our expert for the seminar: Dr. Susan Spiller.