Computerised System Validation (CSV)
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! ▼
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Course Feature
Cost:
Paid
Provider:
Udemy
Certificate:
Paid Certification
Language:
English
Start Date:
2021-01-28
Course Overview
❗The content presented here is sourced directly from Udemy platform. For comprehensive course details, including enrollment information, simply click on the 'Go to class' link on our website.
Updated in [July 27th, 2023]
This course introduces learners to the regulatory requirements for computerized systems in the pharmaceutical industry and explores methods of meeting those requirements. 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. This course 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.
Course Syllabus
Computerised System Validation
Computerised System Validation
Course Provider
Provider Udemy's Stats at AZClass
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