Description
You will gain an overview of the validation process and learn to identify all the activities and documents involved. In addition, you will receive detailed recommendations at various points on how to proceed optimally, enabling you to avoid common pitfalls.
The goal of the course is for each participant to gain an overview of all activities involved in computer system validation (CSV). This includes understanding the nature of the documentation and gaining at least a basic understanding of it through the exercises. If participants already have experience with certain aspects of validation, this knowledge can be integrated into the overall context.
Target Audience
This seminar is intended for:
Employees and department heads who are involved in validation (CSV under GxP) but have limited experience in this area.
(Basic course; some prior knowledge is required), management, IT management, project management, and employees involved in validation projects (resource-optimized validation)
Learning Objectives
After the seminar
– you will have gained an overview of the documentation required for the validation of computerized systems.
– you will be familiar with the GAMP-5 categories for software validation and will be able to incorporate them into your validation models.
– You will know what information a user requirement specification (URS) contains and how it is structured.
– You will have learned about the opportunities and risks of a CSV and know how to assess them using risk management.
You can find the program here.
