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    Csa - Computer System Assurance

    Posted By: ELK1nG
    Csa - Computer System Assurance

    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