Designer Training

This training gives an introduction to VALIDAT, gives an overview of the program, shows you the security according to 21 CFR Part 11. You will learn different concepts and first steps from planning to reporting. You will also learn the functions of VALIDAT, program options and configuration, the steps from planning to data entry and reporting and how to set up interfaces to CDS and LIMS. Another point is reporting and working with text variables, result variables, actptance limits and details of report design. Validations are carried out and templates are presented on the basis of examples.

The focus of this training is the introduction of the Dissolution module. Learn project planning, creating dissolution projects, planning details, planning and data import and USP acceptances. In Reports and Graphics, learn how to create dissolution reports, configure the report, create templates, and learn about dissolution graphics capabilities. In the Compare module, you will create release comparisons with the comparison database, perform f1 and f2 calculations, and demonstrate an import of runs from legacy systems.

In this training you will learn more about the deployment planning and installation of your VALIDAT system. Which modules and interfaces are there? Further points are the installation and database setup, qualification (IQ, OQ, PQ), configuration and configuration files, general user-specific settings, default validations and templates and rolling out settings. On the topic of maintenance and support, you will learn important regular tasks (logs, backups), troubleshooting, how to optimize program performance and tuning, and how to use documentation sources. After that, installation examples are shown from local, server, terminal server and Citrix, the operation in virtualized environments and the interfaces (to CDS and LIMS).

In this training you will get an introduction to the necessary mathematics and statistics. It is about mean, standard deviation, CV, distributions, statistical tests, outliers, trend, normal distribution, homogeneity, etc., regression, fits, confidence intervals and graphs. In the topic of calculation and rounding accuracy, the limitations of calculation methods are discussed. You will learn special calculations on z-scores, Straggler tests, Pure Error and Lack of Fit, f1 and f2 tests.