|
所在平台: Udemy |
课程主页: https://www.udemy.com/course/computer-software-assurance-csa/
课程评论：没有评论
课程名称：计算机软件保障 (CSA) 课程概述：本培训讲座旨在帮助您理解计算机软件保障的草案指南要求，并进一步阐明FDA的通用软件验证原则指南，以及针对医疗设备的21 CFR第820.70和820.72部分。在本次课程中，学员将了解到如何实践性地进行计算机软件保障。培训内容包括：主题与范围的简要介绍、了解您的讲师、监管期望、草案指南推荐、21 CFR 第820的期望、FDA的通用软件验证原则、计算机软件保障风险框架、识别预期用途、确定基于风险的方法、确定适当的保障活动、建立适当的记录以及问答环节。 此外，还有一段讲座将帮助您理解计算机系统检查准备的关键内容，确保计算机系统符合当前良好生产规范（cGMP）。该视频将帮助您为审计做准备，以获得FDA、PIC/S、WHO、EUGMP、TGA等不同监管机构的成功审计结果。 另一段短视频讲座将帮助观众理解质量风险管理原则，说明其实施的简单性和易行性，并通过简单的例子阐释如何达到合规水平。 还有一段培训讲座将帮助您理解与cGXP计算机系统相关的常见错误，强调尽管执行了验证与11部分的合规，但仍需以GMP合规的方式进行程序与系统设置。 最后，还有一段视频讲座将帮助您理解计算机系统验证中的一个重要步骤，即“业务连续性计划”（BCP）。该视频将讲解这一术语的含义，阐明灾难恢复计划与业务连续性计划的不同，并介绍制定稳健的BCP计划的步骤，同时也会提及一些FDA对此主题的引文。 本课程旨在全面提高学员对计算机软件保障以及相关法规和实践要求的理解，帮助企业在满足监管要求的同时，提升其系统的整体合规性和有效性。
This training lecture will help you to understand the draft guideline requirements for computer software assurance and further will provide you clarity about General Principles of Software Validation guidelines by the FDA and 21 CFR parts 820.70 and 820.72 for medical devices. During this session, the viewers will learn about how to assure computer software practically. The training contents are detailed below; Brief introduction of the topic and scope Know your Trainer Regulatory Expectations Draft Guideline Recommendation Expectations from 21 CFR part 820 General Principles of Software Validation - FDA Computer Software Assurance Risk Framework Identifying the Intended Use Determining the Risk-Based Approach Determining the Appropriate Assurance Activities Establishing the Appropriate Record Q & A session.The other lecture will help you to understand the keys of Inspection Readiness For Computerised Systems. How to ensure cGMP compliance with respect to computerized systems. This video will help to prepare for audits and successful audit results by different regulatory agencies for example FDA,PIC/S,WHO,EUGMP,TGA etc. This short video lecture will help you to understand overall expectations about computerized systems from different regulatory agencies.Another short video lecture will help viewers to understand Quality Risk Management principles, how it is simple and easy to implement, and achieve the compliance level. We have explained this with simple examplesThere is more training lecture will help you to understand the common errors related to cGXP computerized system. Irrespective of performing validation and compliance to part 11. The purpose of this video to make procedures and systems in organizations in GMP GMP-compliant manner.There is one video lecture that will be helpful in understanding the very important step of computerized system validation. This step is,"Business continuity plan" (BCP). This video will take you through the meaning of this terminology, why a disaster recovery plan is not the same as a business continuity plan, and what are steps involved in developing robust BCP plans. Also, this video will make you aware of some FDA citations about this topic.
