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所在平台: Udemy |
课程主页: https://www.udemy.com/course/validation-and-maintenance-of-computerized-systems/
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课程名称：基于GAMP 5第二版的计算机系统验证与维护 课程概述：本课程旨在教授计算机系统验证与维护的基础知识，依据GAMP 5第二版开展学习。学习者将了解系统分类、风险管理、验证系统循环以及维护生命周期等基本概念。这些基础知识对于验证您第一个简单系统至关重要。 课程范围： - 定义、法规、指南 - GAMP 5第二版的新内容 - 系统生命周期(SLC)、V模型、验证计划 - 需求规范 - 风险管理与风险分析 - 资格确认阶段、验证报告 - 操作流程与系统维护 课程目标： - 获取计算机系统验证的知识 - 培养制定系统验证与维护程序的能力 - 具备在符合GxP要求的环境中审核验证文件的能力 GAMP 5（良好自动化制造规范）是由国际制药工程学会（ISPE）制定的一套指南和最佳实践，专门用于自动化系统的验证与确认，这些系统应用于制药和生物技术行业。GAMP 5提供了一种结构化的方法，确保这些自动化系统的设计、安装和运行符合监管要求，从而确保产品质量和患者安全。 总之，GAMP 5第二版是制药和生物技术公司维护其自动化系统质量和完整性的关键资源。遵循其原则和指南，组织可以提高其制造过程和产品的可靠性与安全性，同时遵守行业法规。
Start by gaining fundamental knowledge about computer system validation and maintenance based on the GAMP 5 second edition. Understand concepts such as system categorization, risk management, validation system cycles, and maintenance life cycles. This foundational understanding is crucial for validating your first simple system. Scope of the Course:Definitions, Regulations, GuidelinesWhat's New in GAMP 5 Edition 2SLC, V-Model, Validation PlanRequirement SpecificationRisk Management and Risk AnalysisQualification Phase, Validation ReportOperation Processes & System MaintenanceCourse Objectives:Gain knowledge about Computer System ValidationDevelop the ability to create your procedures for validating and maintaining systemsBecome proficient in reviewing validation documentation in a GxP-compliant environment."GAMP 5, which stands for Good Automated Manufacturing Practice is a set of guidelines and best practices developed by the International Society for Pharmaceutical Engineering (ISPE). It specifically addresses the validation and qualification of automated systems used in the pharmaceutical and biotechnology industries. GAMP 5 provides a structured approach to ensure that these automated systems are designed, installed, and operated in a manner that meets regulatory requirements and ensures product quality and patient safety.In summary, the GAMP 5 2nd edition is a vital resource for pharmaceutical and biotechnology companies seeking to maintain the quality and integrity of their automated systems. By following its principles and guidelines, organizations can enhance the reliability and safety of their manufacturing processes and products while staying in compliance with industry regulations.
