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所在平台: Udemy |
课程主页: https://www.udemy.com/course/quality-risk-management-in-pharmaceuticals/
课程评论：没有评论
课程名称：制药行业质量风险管理 ICH Q9(R1) 课程概述：本培训讲座将帮助您了解质量风险管理的基本概念和范围，包括国际会议和谐组织（ICH）质量指南的简介及对质量风险管理新版本指南ICH Q9(R1)的更新解读。您将学习到如何有效管理风险及其带来的利益，以及ICH Q9在ICH Q8和ICH Q10中的作用。课程将深入探讨质量风险管理（QRM）过程，并介绍如何使用失效模式影响分析工具执行QRM。此外，将介绍行动优先级表概念/热图矩阵，课程最后设有提问环节以答疑。 本课程包括一段简短的视频讲座，帮助您理解质量风险管理原则，展示其简单易实施的特性及其合规性达成方式，配以简单实例加以说明。最后一段视频将进一步讲述良好审查实践，包括食品药品管理局（FDA）的引用实例、审查的监管期望、良好审查实践的10个关键原则、如何培训审查人员等内容。 总体而言，本培训课程将引导您理解质量风险管理、更新的ICH Q9(R1)指南，并通过实际案例和基于风险的方法论介绍良好审查实践。
The training lecture will help you to learn a brief introduction of the topic and scope Brief on ICH Quality Guidelines and Understanding guidelines for Quality Risk Management Updates in the new version of the guideline ICH Q9 (R1) Understanding of - Managing your risk has its own rewards. Role of ICH Q9 with ICH Q8 and ICH Q10 Practical understanding of Quality Risk Management (QRM) process and how to perform QRM by failure mode effect analysis tool. Action Priority Tablet concept/Heat map matrix Vote of Thanks - Q & A session.Further, there is a small video lecture that will help you 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 examples.The last lecture video will help you to learn further about Good Review practices. This training will include, some examples of Food and Drugs Administration (FDA) citations, regulatory expectations about the review, 10 key principles about good review practices, how to qualify reviewers, and many more. Overall this training session will take you through an understanding of quality risk management, what is updated in the revised ICH Q9(R1) guideline, with practical examples and good review practices based on risk-based approach.
