Inspections and audits often identify weaknesses in the validation of computerized systems. However, it is essential that computerized processes and systems in the pharmaceutical industry have the required quality, integrity and reliability.
The aim of GMP is to manufacture pharmaceutical products safely and effectively. Computer validation therefore plays a central role in ensuring product quality and patient safety.
In 4 interrelated modules, you will learn the practice of computer validation step by step: you will learn the individual phases and the necessary documentation. Workshops consolidate the implementation in practice. The procedure according to GAMP 5 is integrated in all modules. The training is aimed at practitioners and anyone who needs a sound knowledge of computer validation processes.
The computer validation modules are freely selectable. All modules are self-contained. The module series does not necessarily have to begin with the module “Fundamentals, Rules, GAMP 5”. However, we recommend starting with this module to gain an initial insight and overview. This will enable you to better understand the valuable information provided by the authority inspector.
Certificate: Expert in computer validation
Each module ends with a voluntary performance assessment. Your success will be certified. If you pass all four modules, you will be awarded the certificate as an expert in computer validation.
