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Computer System Validation is largely used in the working structure of all life science fields. It becomes a valuable and very useful mechanism which helps the quality of performance as well production in the Pharmaceutical business. The ultimate goal of any CSV process is to promise the best functionality of systems by making sure that they are compliant with all regulations, laws and rules which have been previously accepted. Validation is directed towards pharmaceutical and medical product manufacturing companies.
Computer System Validation is of high demand because the properly conducted validation process will be able to prevent software problems from affecting the production environment. Failure to take correct actions may result in financial penalties, economic imbalance and, even, eventual bankruptcy.
Who is this training suitable for?
Clinical Trial Managers
Regulatory Affairs professionals
Students and academic staff
Full Training Content
Objectives of Validation
What computer systems must be validated, when and by who it should be done?
When should a computer system be validated?
Computer System Validation in GxP
Electronic Records and Electronic Signatures
System Development Life Cycle (SDLC) and Validation Methodology
Corporate Solutions and Certification
This training is also available as a corporate solution, which allows professionals with administrative functions, such as R&D, Training, QA, Clinical Operation, HR Managers, to manage and monitor the whole learning process/curve: