Training

CSV Solutions offers training to help your business bring its personnel up to speed on the requirements of the regulatory bodies in relation to Computerised System Validation. Our experienced trainers have worked for many years validating a wide range of GxP Computerised Systems for both Pharmaceutical and Medical Devices companies. At our training sessions the participant with get an opportunity to put into practise what they have learnt and to draw from the wealth of knowledge that our trainers possess. Training is offered through scheduled courses or as in company training.

We currently offer the following courses;

Introduction to Computerised Systems Validation

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Course Aims:

To provide a sound understanding of the concepts and deliverables associated with Computerised Systems Validation as required by the Pharmaceutical, Medical Device and Biotechnology Industries and associated regulatory bodies. Attendees will become familiar with the expected deliverables associated with Computerised System Validation based on GAMP5 guidelines. Regulations associated with CSV will be introduced.

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Spreadsheets for GxP Environments

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Course Aims:

Did you know that the FDA uses spreadsheets within in its own laboratories and have their own internal guidance on designing and validating spreadsheets? Many companies use spreadsheets for GxP activities but fail to validate them. When appropriately designed and validated spreadsheets can be a very simple and useful tool in the GxP environment. This training course aims to provide participants with the necessary skills to design and validate spreadsheets for GxP environments that meet the needs of regulatory bodies such as the FDA.

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Testing GxP Computerised Systems

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Course Aims:

To provide participants with the necessary skills to plan, execute, review and approve testing of GxP computer systems. During this training session learners will be introduced to the key concepts of computer system testing as outlined by GAMP Good Practise Guide: Testing of GxP Systems. Participants will be shown how to use Risk Management to reduce testing effort, leading to more effective and efficient validations.

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