Computerised System Validation (CSV)

Learners: 1,274

Instructor: Hitendrakumar Shah

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This course provides a comprehensive introduction to Computerised System Validation (CSV) for new learners. It covers topics such as categorisation of software and hardware as per GAMP 5, different validation strategies, developing URS, FRS, FAT, SAT, IQ, OQ and PQ, test strategies, validation master plan and validation master report concept, and common questions and answers. It is beneficial for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors, as well as software vendors, auditors, and quality staff involved in GxP applications. This course explores tried, tested, and internationally recognized methods of meeting regulatory requirements for computerized systems in the pharmaceutical industry. Click now to learn more!▼▲