Csa - Computer System Assurance

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Csa - Computer System Assurance
Published 9/2023
MP4 | Video: h264, 1280x720 | Audio: AAC, 44.1 KHz
Language: English | Size: 211.39 MB | Duration: 0h 39m

Computer System Assurance, its core concept, and its integration in GAMP 5's second edition are of paramount importance

What you'll learn
Learn about Computer System Assurance
Discover how CSA influences GAMP 5 2nd edition
Explore risk assessment in CSA
Familiarize yourself with new types of tests
Explore critical thinking
Requirements
It is good to have basic knowledge of computer system validation and GAMP 5.
Please look my previous course Validation and maintenance of computerized systems
Description
The goal of the courseLearn about Computer System Assurance (CSA)Discover how CSA influences GAMP 5 2nd editionExplore risk assessment in CSAFamiliarize yourself with new types of tests in CSAExplore critical thinkingScope of the courseComputer System Assurance background and historyNew Approach to Computer System AssuranceRisk assessment in Computer System Assurance (CSA) and Computer System Validation (CSV)CSA test typesRequirements and test case examplesComputer System Assurance Versus Current Validation ApproachComputer System Assurance (CSA) in the context of GxP (Good Practice) refers to the specialized set of practices and processes implemented within highly regulated industries like pharmaceuticals, biotechnology, and healthcare to ensure that computer systems used in the development, manufacturing, testing, and distribution of products adhere to regulatory requirements and maintain data integrity. GxP encompasses various guidelines and regulations, such as Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Good Manufacturing Practices (GMP), among others.Compliance with GxP regulations is critical for industries where product quality and patient safety are paramount. Failure to adhere to these regulations can result in severe consequences, including product recalls, regulatory fines, and damage to an organization's reputation. Computer System Assurance within GxP environments is a systematic approach to mitigate these risks and ensure the reliability and compliance of computer systems used in regulated processes.
Overview
Section 1: Wstęp
Lecture 1 Introduction
Lecture 2 CSA background and history
Section 2: Core concepts of CSA
Lecture 3 New approach to Computer System Assurance
Lecture 4 Risk assessment in Computer System Assurance and Computer System Validation
Lecture 5 Test types
Lecture 6 CSA Risk Assessment examples (requirements and test cases)
Lecture 7 Computer System Assurance & current validation approach
computer system validation specialist,software quality assurance,software tester,GxP specialist

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