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所在平台: Udemy |
课程主页: https://www.udemy.com/course/production-validation-training-in-medical-devices-iqoq-pq/
课程评论：没有评论
课程名称：医疗器械生产验证 课程概述： 本课程旨在深入探讨医疗器械领域中的验证过程。涵盖的主要内容包括验证的基本概念和定义、相关的标准、法规和立法、验证的范围和责任、验证计划及验证协议的制定。课程将详细讲解安装验证（IQ）、操作验证（OQ）和性能验证（PQ）的过程，帮助学员理解如何识别不当情况以及不当数据的检测方法。此外，还关注验证的评估、过程可追溯性、再验证和验证确认的相关内容。 课程中将结合93/42 EC医疗器械指令、745/2017医疗器械法规以及EN ISO 13485:2016质量管理体系标准中的基本要求，展示生产过程及验证阶段，如何处理和批准。课程采用学术培训模式，系统讨论从最终产品的可接受性到所有相关过程的教育内容，以具体实例和易于理解的方式进行说明。此外，还会涉及质量管理体系、产品实现的规划和相关术语的识别、设计与开发、生产和服务提供控制、产品清洁、有效性、标识、可追溯性和产品存储等标准事项。 本课程为医疗器械生产验证提供全面的理论基础和实践指导，适合相关专业人员和行业从业者参与学习。
1 What is Validation2 Terms and definitions3 Related Standards, Regulations and Legislations4 Scope5 Responsibility6 Validation Planning/Validation Protocol7 Determination of IQ (Setup)Validation Process(s)8 (OQ) Operation VALIDATION9 (PQ) Performance VERIFICATION10 Detection of Inappropriate Situations/Inappropriate Data11 EVALUATION OF VALIDATION12 Process Traceability13 Re-validation14 Confirming Validation15 Validation Protocol Examples-What are the production process and verification stages, which constitute the basic requirements of 93/42 EC Medical Device Directives and 745/2017 Medical Device Regulatory Directives and EN ISO 13485:2016 Quality Management System Standards, how they are processed, how they are approved in our Production validation training course with content such as It is an academic education training in which all processes from and to the acceptability of the final product are discussed. The basic requirements in education are given with concrete examples and in an understandable way. At the same time, the quality management system,7 Product Realization ,7.1 Planning the Realization of the Product7.2.1 Identification of Product-Related Terms7.2.2 Review of Product Terms7.3 Design and Development7.5 Production and Service Provision7.5.1 Control of Production and Service Provision7.5.2 Cleaning of the Product7.5.6 Validity of Production and Service Provision Process7.5.8 Identification7.5.9 Traceability7.5.11 Product Storage-Standard items are also mentioned and explained simultaneously.
