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所在平台: Udemy |
课程主页: https://www.udemy.com/course/part-11-compliance-for-computerised-systems/
课程评论：没有评论
课程名称：计算机化系统的第11部分合规性 课程概述：如今，许多制药公司都在寻找符合第11部分合规要求的计算机化系统。为了确保合规，许多公司仅专注于计算机系统的验证。然而，仅仅进行验证活动并不能确保系统符合第11部分的要求。那么，接下来该做什么呢？为了解答这个问题，我创建了本课程。在这里，您将学习到美国FDA针对21 CFR第11部分、EUGMP附录11的具体要求，以及数据完整性的一些关键方面。 在课程中，我们将全面讨论21 CFR第11部分的理解、指南的应用、对第11部分要求的总体方法、FDA指导的明确性、合规所需的文件、特定于第11部分要求的方法，以及EUGMP附录11与21 CFR/eCFR第11部分之间的主要区别。此外，我们将强调，不仅要遵循这些指南，还需要理解数据完整性的要求。我们将讨论一些关于数据完整性的FDA引用、数据完整性的介绍、如何设计系统和流程以确保数据的完整性、控制数据完整性的空白格式的角色、控制主模板、实际实施的差距分析策略、数据完整性培训、呈现数据完整性状态、质量保证的角色/监督和触发思考过程的要点等。 此外，本课程的视频讨论将帮助您理解指导方针的预期和实际方法。我还制作了一些学习视频，内容涉及如何确保计算机化系统的审计准备以及公司在确保第11部分合规性时常犯的错误。总体而言，这门课程将指导您如何确认您的计算机化系统符合第11部分的要求。请记住，仅凭供应商提供的一张证书或获得一张证书，并不能确保您的系统符合第11部分的合规性。
Now a days, many pharmaceutical companies are looking for the part 11 compliant computerised systems. To ensure part 11 compliant, they just focus on validation of computerised system. I want to inform you all that, only validation activity can not ensure your computerised system as part 11 compliant. So, then the next question comes in to mind is, what to do? For answering this only, I have created this learning course. Here, you will learn exact requirements of USFDA as per 21 CFR part 11, EUGMP annex 11 and also some key aspects of data integrity. During this through discussion, we will discuss, 21 CFR Part 11 Broad Understanding, Application of guide, Overall approach to part 11 requirement, Clarity provided by FDA on guidance, Documents identified for compliance, Approach specific to Part 11 requirements, Key differences between EUGMP annex 11 & 21 CFR/eCFR part 11. Additionally as we will explain that, not only these guides to be followed. But also need to understand the data integrity requirements. We will discuss some FDA citations on Data Integrity, Introduction to Data Integrity, How to design system and Processes to assure integrity of Data, Role of Blank formats in controlling Data Integrity, Controlling master templates, Practical implementation - GAP analysis strategy, DI Training, Presenting DI status, QA role/oversight, Points triggering the thought process etc.Furthermore, this discussion videos will take to understand the guideline expectations and practical approach. Additionally, I have made some learning videos for how to be ensure audit preparedness for compurterised systems and what are the common errors companies are making while ensuring part 11 compliance. Overall this complete learning course will guide you for claiming your computerised system as part 11 compliant. Remember, just by providing one certificate or getting one certificate from computerised system supplier can not ensure your system is part 11 compliant.
