|
所在平台: Udemy |
课程主页: https://www.udemy.com/course/medical-device-single-audit-program-mdsap-training-course/
课程评论：没有评论
**课程名称：医疗器械单一审核方案 (MDSAP) 培训课程** **课程概述：** 本入门级培训课程旨在为学习者提供医疗器械单一审核方案（MDSAP）框架、目标和法规要求的扎实基础。课程适合那些希望深入了解 MDSAP 如何运作、哪些监管机构参与其中以及 MDSAP 对医疗器械合规性有何影响的专业人士。 MDSAP 允许通过一次审核来满足多个国家/地区的要求，包括： * 美国 (FDA) * 加拿大 (Health Canada) * 巴西 (ANVISA) * 日本 (PMDA & MHLW) * 澳大利亚 (TGA) **课程目标受众：** * 质量保证 (QA) 和法规事务 (RA) 专业人士 * 医疗器械制造商及合规团队 * 内部审计师及咨询顾问 * 工程师及研发专业人士 * 运营及生产经理 * 所有为 MDSAP 审核做准备或参与 MDSAP 审核的人员 **学习收获：** * 了解 MDSAP 的目的、范围和益处 * 熟悉五个参与的监管机构及其要求 * 掌握 MDSAP 如何与 ISO 13485:2016 标准对齐 * 理解 MDSAP 的审核模型和流程 * 认识 MDSAP 在法规合规中的重要性 通过本课程，您将清晰地掌握 MDSAP 的结构、审核流程、优势，以及它如何提高跨国市场的医疗器械制造商的运营效率。本次培训将帮助您自信地有效应对监管审核。 **先决条件：** 无需 MDSAP 或审计经验，适合初学者。课程内容也适合寻求法规知识更新的经验丰富的专业人士。
The Introduction to the Medical Device Single Audit Program (MDSAP) training course provides a foundational understanding of the MDSAP framework, objectives, and regulatory requirements. This course is designed for professionals seeking to gain insights into how MDSAP works, which regulatory authorities participate, and how it affects medical device compliance.MDSAP allows a single regulatory audit to meet the requirements of multiple countries, including:- United States (FDA)- Canada (Health Canada)- Brazil (ANVISA)- Japan (PMDA & MHLW)- Australia (TGA)This course is ideal for:-Quality Assurance (QA) & Regulatory Affairs (RA) professionals- Medical Device Manufacturers & Compliance Teams- Internal Auditors & Consultants- Engineers & R & D Professionals- Operations & Production Managers- Anyone preparing for or involved in MDSAP auditsWhat You'll Learn- The purpose, scope, and benefits of MDSAP- The five participating regulatory authorities and their requirements- How MDSAP aligns with ISO 13485:2016- The MDSAP audit model and process- The importance of MDSAP in regulatory complianceBy taking this course, you will gain a clear understanding of MDSAP's structure, audit process, benefits, and how it improves efficiency for medical device manufacturers operating in multiple global markets. This training will help you build confidence in navigating regulatory audits effectively.No prior MDSAP or auditing experience is required, making this course accessible to beginners. It is structured to benefit both new learners and experienced professionals seeking a regulatory refresher.
