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所在平台: Udemy |
课程主页: https://www.udemy.com/course/process-validation-explained-in-simple-terms/
课程评论：没有评论
课程名称：《医疗器械工艺验证：ISO 13485、IQ OQ PQ》 课程概述： 本课程分为六个部分，旨在用简单的术语解释工艺验证的重要性。第一部分介绍工艺验证及其必要性，讨论需要进行验证的决定步骤，重点关注医疗器械行业的工艺验证，讲解ISO 13485、FDA质量体系法规（QSR）和FDA 21 CFR 820等法规如何影响工艺验证。此外，课程还阐述三种不同类型的验证。 第二部分讲解工艺验证的执行过程，包括用户需求规格、设计确认、安装确认（工厂验收测试和现场验收测试）和操作确认，并展示操作确认的示例。同时，会解释性能确认的内容。 第三部分将探讨工艺能力的含义及其与工艺验证的关系，理解工艺能力比率和工艺能力指数，学习工艺模型、控制限和行动限，以及实验设计在操作确认中的应用。 第四部分关注风险管理，指出医疗器械法规中风险管理的必要性，解释其在验证过程中的作用，并总结ISO 14971标准如何运用于风险管理中。 第五部分讨论工艺验证所需的文档，包括过程验证文档、验证主计划、验证计划、变更控制、校准、预防性维护及验证总结报告。 最后，第六部分按时间顺序讲述美国生命科学行业法规的发展，理解这些法规如何纳入工艺验证。 这门课程将对想要深入理解工艺验证的人大有裨益，尤其适合以下领域的人员：运营管理、制造工程师、工艺工程师、质量工程师、法规事务、研发工程师、以及需要掌握工艺验证的学生和创业者。
This Course is broken into six sections. The objective of the course is to explain process validation in simple terms:Section 1 will give an introduction to process validation and explain why we need it.We will discuss the steps we take to decide if we need to validate.The course focuses on medical device process validation. We will explain the regulation governing process validation within the medical device industry. This will explain how ISO 13485, the FDA Quality system regulation (QSR) and the FDA 21 CFR 820 fit into regulation that governs process validation.Please remember the course explains process validation so it can benefit people interested in manufacturing in any industry.This section will explain the 3 different types of validation.In section 2 we will explain how process validation is performed.We will explain what the user requirement specification is.We will explain design qualification.Install qualification will be explained which contains the factory acceptance test and the site acceptance test.We will explain what an operational qualification is. We will demonstrate an operational qualification.We will explain what a performance qualification is.Section 3 will explain what is meant by process capability and how it relates to process validation.We will understand the process capability ratio and the process capability index.We will understand the process model, control limits and action limits.We will understand the Design of experiments and how this is used in the operational qualification part of process validation.Section 4 Risk ManagementWe will point out where risk management is required within the medical device regulation.We will explain how risk management fits into the validation process.We will summarise how the ISO standard 14971 is utilised and therefore how risk management is applied.Section 5 Process Validation DocumentationIn this section we will understand the documentation which needs to be created in order to complete process validation. We will explain terms as follows:· Process Validation Documentation.· Validation Master Plan.· Validation Plan.· Validation Change control.· Calibration within Process Validation.· Preventive Maintenance within the validation process.· Validation Summary ReportSection 6 will explain in chronological steps how regulation developed for the life science industry in the U.S. We will study this and understand how the regulation developed to include process validation.The course will be of great benefit to anybody that really wants to understand process validation in simple terms. It can be a very useful training package for the following disciplines:· Operations.· People managers.· Manufacturing Engineers.· Process Engineers.· Quality Engineers.· Regulatory Affairs.· Research and development Engineers.· Process and development Engineers.· Students who need to really understand process validation in simple terms.· Entrepreneurs or small medium start-up companies that need to develop and understand the manufacturing process.
