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所在平台: Udemy |
课程主页: https://www.udemy.com/course/21-cfr-part-820-medical-device-qsr-practice-exam/
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课程名称：21 CFR Part 820（医疗器械质量系统法规）- 实践考试 概述：21 CFR Part 820 是美国医疗器械制造商的质量系统法规的监管要求。这项法规不仅适用于美国，许多其他国家也从中汲取灵感，制定自己的法规或将其作为指导。作为医疗器械制造商质量系统的关键法规，掌握这项内容对质量或监管专业人士以及医疗器械行业的初学者至关重要。本“知识验证考试”旨在帮助您检查和验证对 21 CFR Part 820 法规及其基本概念的理解。 增值提醒：通过考试将获得由讲师颁发的证书。只有在考试中达到 80% 以上的学员才能申请证书，证书的申请需提交合格证据，并在月末发放。 考试组成：考试内容涵盖法规的所有子部分，您将被评估以下方面的知识：一般条款、质量系统要求、设计控制、文件控制、采购控制、识别与可追溯性、生产与过程控制、验收活动、不合格产品、纠正与预防措施、标签和包装控制、处理、储存、分发与安装、记录、服务和统计技术。 思考提示：请了解您所掌握的 21 CFR Part 820 知识。如果您已经参加了相关课程并在 QSR 方面工作，认为自己是专家，那么请慢下来！加入本考试进行自我评估！无论是需要进一步学习，还是希望通过顺利完成考试证明自己的知识和专业能力，您都将处于双赢的局面。 好消息：未来我们将添加更多内容，例如案例研究以供练习测试。如果您觉得自己知识不足，可以从 Udemy 或讲师处学习 21 CFR Part 820 相关课程以提高自己的知识水平。 一个月退款保证：请注意，报名此课程享有一个月 100% 无条件退款保证，这意味着您在注册过程中的风险为零。 提问与投诉：课程右侧的讨论区可用于讨论特定问题并报告您在课程内容中遇到的问题。 课程报名：请点击页面右上方的“报名此课程”按钮，按照指示进行注册和支付课程费用。
21 CFR Part 820 - Quality System Regulation is the set of regulatory requirements on Quality System for medical devices manufacturers in the U.S.A. The regulation is not only applied in the U.S. but also many other countries have taken inspiration from it for making their own regulations or adopting it as a guidance. It is one of the important regulatory document on medical device manufacturer's Quality System. If you are a quality or regulatory professional or beginner in the medical devices industry, you should check your expertise in Quality System Regulation (QSR). This "knowledge validation exam" helps you to check and validate your knowledge on 21 CFR Part 820 regulation and its fundamental concepts.--------------------------------------------------------------Value Addition Alerts: Passing Certification Awarded By InstructorRoad Map for Further LearningCertification: Udemy does not provide certification for exams, they only do in the case of Video Courses. But the great news here is, we have empowered our paid students to have a certificate, once they qualify by 80% in the exams. It is a manual process, in which learners our requested to submit evidence of qualification, and apply for the certificate. The certificates are issued at the end of a month.--------------------------------------------------------------Exam CompositionThe exam is based on all sub parts of the regulation. Therefore You will be assessed when you take this online exam in following areas (Course Objectives):General ProvisionsQuality System RequirementsDesign ControlsDocument ControlsPurchasing ControlsIdentification and TraceabilityProduction and Process ControlsAcceptance ActivitiesNonconforming ProductCorrective and Preventive ActionLabeling and Packaging ControlHandling, Storage, Distribution, and InstallationRecordsServicingStatistical Techniques--------------------------------------------------------------Food for ThoughtBe Familiar with 21 CFR Part 820 knowledge which you hold...If you think you are an expert in 21 CFR Part 820 after taking courses on the subject and working with QSR...You need to hold on!Join this exam and self assess yourself!Maybe you need to learn and learn...Or you can prove your knowledge and expertise by successfully completing this exam.Both ways, you are in a win-win situation.--------------------------------------------------------------Good news: We will be adding more content for example case studies to practice tests in the future. If you feel that you lack the knowledge you can take 21 CFR Part 820 courses from Udemy or the instructor to guide you on gaining 21 CFR Part 820 knowledge.--------------------------------------------------------------One Month Money Back Guarantee: Don't forget One Month 100% Money Back Guarantee without inquiry. This means you have unconditionally no risk when registering to this Course.--------------------------------------------------------------Ask Questions & Report Complaints: Discussion forum on the right side of this course can be used to discuss specific queries and report problems you are facing about the content of the course.--------------------------------------------------------------Take this course: Follow the "Take This Course" Button by clicking at the Top Right Hand Side of the Page. Proceed with the instructions and follow it to register and pay for the course.
