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所在平台: Udemy |
课程主页: https://www.udemy.com/course/iqoqpq-processvalidationmedicaldevices/
课程评论：没有评论
《医疗器械工艺验证基础：IQOQPQ》课程概述： 本课程深入探讨了I类、II类及III类医疗器械的工艺验证，旨在帮助学员掌握满足ISO 13485标准和FDA 21CFR 820.75法规要求所需的工具与知识。课程强调工艺开发、质量原则和项目管理在工艺验证中的应用，以满足法规、合规性和客户需求。 课程内容高度定制化，针对不同产品、医疗器械等级、团队规模和制造方法进行讲解。通过介绍新产品上市验证的各个阶段和相关链接，帮助学员成功实现上市。课程涵盖了设计、工艺工程、质量保证（QA）和质量控制（QC）实验室等多元视角，提供全面的、整体性的指导。 课程着重于工艺验证中的跨部门协作，涵盖工程、质量和运营等部门的职责与协作流程。理解这些职能间的交接点至关重要。课程指出，在初步的几次产品上市中，学员将能够识别流程和瓶颈，并在后续产品上市时，通过团队对工艺的成熟度提升，实现更成功、更流畅的工艺验证。 对于标准和FDA要求的模糊性，本课程提供了Instructor的专业指导和解读。学完课程后，学员将全面了解工艺验证的法规要求，并获得消除组织内部瓶颈、顺利执行工艺验证的实用方法。 祝您在这一过程中一切顺利！
Process Validation of Class 1/2/3 Medical Devices shall meet ISO 13485 standard and FDA 21CFR 820.75 requirements. The objective of the course is to provide the course audience with the tools and knowledge to use the Process development, Quality principles and Program management to perform their Process Validation activities to meet regulatory, compliance and customer requirements.It is a vast subject completely based on YOUR products, medical device class, team size, manufacturing method etc.The course is explained with various phases and links to make a New Product Launch Validation successful. A Designer doesn't get a manufacturing perspective, a Process Engineer doesn't understand a QE and QC lab perspective, the Instructor covered all those important bases to make this course holistic to manage and be successful.This course will teach you cross collaboration activities involved in Process Validations from Engineering responsibility to Quality to Operations. This is a high collaboration work with various hand offs between various functions in your organization, but once trained on the overall process, you will be ready to start. The first 2 product launches will help you identify the processes and the bottlenecks within, and when you are ready to launch your third product, your team's maturity on the process will help a lot to successfully & smoothly do your Process Validation. The standards and FDA requirements have a lot of room for interpretation, the Instructor has taken his best diligence to provide guidance through this course. At the end of this course, you will have been provided with an overview of the Process Validation regulatory requirements and what you need to perform them without any bottlenecks in your organization.A very good luck on this journey.
