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所在平台: Udemy |
课程主页: https://www.udemy.com/course/computerised-system-validation-csv/
课程评论：没有评论
课程名称：计算机系统验证（CSV） 课程概述：本课程已更新，包括21 CFR第11部分的最新内容以及电子版的CFR第11部分。该基础课程旨在介绍制药行业中计算机化系统的监管要求，并探讨满足这些要求的经过验证的国际公认的方法。监管指导提供了一个务实且有效的框架，以实现适合预期用途并符合当前监管要求的计算机化系统。课程将提供计算机系统合规性的原则和整体概述，包括根据GAMP 5对软件和硬件的分类、不同的验证策略等内容。课程中将重点讨论URS（用户需求规范）、FRS（功能需求规范）、FAT（工厂验收测试）、SAT（现场验收测试）、IQ（安装验证）、OQ（操作验证）和PQ（性能验证）的制定。此外，本课程还将详细介绍测试策略，尤其是黑箱策略，以便验证人员按照视频中的指导轻松进行验证。在本学习环节中，我们将阐明验证主计划和验证主报告的概念。最后，课程结束时将回答许多专家常见的问题。 该培训课程将为所有使用cGXP计算机化系统执行工作职能的人提供帮助，特别适合在医疗保健、临床试验、生物制药和医疗器械领域工作的监管、临床和IT专业人员。对于涉及GxP应用的软件供应商、审计人员和质量人员来说，这门课程是必不可少的。
This course has been updated to include the update on 21 CFR Part 11 and also electronic version of CFR part 11. This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements.Regulatory guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements.The course will provide principles and an overview of the overall computer systems compliance. This course includes categorisation of software and hardware as per GAMP 5, the different validation strategies etc. More discussion will be on developing URS, FRS,FAT,SAT,IQ,OQ and PQ. This session will explain you further the test strategies specifically black box strategies so that the validation person can easily do the validation by following the instructions given in this video.In this learning session, we will clear your validation master plan and validation master report concept. Lastly some common questions by many experts and answer to these questions are available at the last of session.Training Course will benefit all who use cGXP computerised systems to perform their job functions and is ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. It is essential for software vendors, auditors, and quality staff involved in GxP applications.
