Computerised System Validation (CSV)

Course Feature

Cost

Paid
Provider

Udemy
Certificate

Paid Certification
Language

English
Start Date

2021-01-28
Learners

No Information
Duration

No Information
Instructor

Hitendrakumar Shah

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3.8

1,274 Ratings

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 Overview

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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

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