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所在平台: Udemy |
课程主页: https://www.udemy.com/course/master-pharmaceutical-quality-management-system/
课程评论：没有评论
课程名称：制药质量管理体系硕士课程 课程概述：质量管理体系（QMS）是制药行业的核心概念。如果您计划注册一个制造场所、制药产品或医疗设备，您必须遵循质量管理体系（QMS）的要求，以确保产品质量，这也是全球各个卫生管理机构关注的主要议题。 在本课程中，您将学习： - QMS的简介和目标 - 良好生产规范（GMP）的基本知识 - 质量标准 - GMP、GX、PGDP和GMP培训 - 过程验证和风险管理 质量管理体系是一个正式的系统，记录了实现质量政策和目标的过程、程序和职责。QMS有助于协调和引导组织的活动，以满足客户和监管要求，并持续提高其有效性和效率。 课程将深入探讨质量管理体系的概念，包括三个质量层次、管理层在QMS中的角色、QMS的目标，以及QMS各要素如何整合形成最终的QMS。我们还将实践在制药行业中的QMS，以理解其意义和应用，意识到质量是一个持续的过程，贯穿于产品生命周期的各个阶段。 此外，我们将研究ISO标准的定义、历史、发展及其各条款的变化，以及ISO的成果，了解这些成果在制药行业中的重要性。良好的生产规范（GMP）作为提交文档的核心概念将被详细讨论，并扩展到更广泛的GXP范围，强调文档的重要性，因为制药行业本质上与文件和记录管理密切相关。 课程结束时，我们将进行QMS概念与应用的人员培训及过程验证的学习。准备好与我们一起深入这个有趣的学习旅程吧！
The quality management system (QMS) is the backbone concept in the pharma industry, if you are planning to register a manufacturing site, pharmaceutical product, or medical device, in all cases, you have to have complied with the quality management system (QMS) to ensure quality, which is the major topic of concern by all health authorities globally.What will you learn?Introduction QMS Objectives Fundamentals of GMP Quality Standards GMPGXPGDPGMP Training Process Validation Risks The QMS is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. The QMS will help to coordinate and direct an organization's activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.In this course we will dive deeply together into the QMS, to understand the concept behind it, the 3 levels of quality, the role of the management towards QMS, the QMS objectives, how the elements of the QMS are integrated together to come up with the final QMS. Then we will practice QMS in the pharma industry, to understand the meaning and application of QMS in the pharma industry to understand that quality is a continuous process rather than just an activity that comes after the finishing of any process in the pharma industry quality is involved in all stages of any product Lifecycle, conations with it and going in parallel together with it.and then will test the behavior towards the QMS, quality standards, and pharmacopeias behind it. Then we will explore the ISO, its definition, history, development, its clauses over the years, what is new in these clauses, and finally, the ISO outcomes which are our main target in the pharma industry out of the application and be complied with ISO. Then comes the GMP, the core concept and document of the quality for any kind of submission in any countryand then expanding to the wider scope of the GXP, ending with documentation, which is very crucial as the pharma industry is all about documentation and keeping records.Then we will Complete our course with personnel training on the QMS concepts and application and finally process validation. Let us prepare ourselves for the interesting dive, let's go.
