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所在平台: Udemy |
课程主页: https://www.udemy.com/course/risk-management-medical-devices/
课程评论：没有评论
课程名称：风险管理大师班 [2024] 认证课程 课程概述：本课程是Udemy上最全面的风险管理课程，旨在教会您成为医疗器械、制药工业及任何进行风险管理活动的企业中的风险管理和质量管理体系（QMS）主题专家。无论您当前的技能和经验如何，在完成本课程后，您将能够自信地与医疗器械行业的专家沟通有关质量管理体系（QMS）及风险管理（RM）标准和法规的信息。 到课程结束时，您将熟练掌握创建复杂的风险评估和风险测量文档的能力，包括PFMEA、DFMEA、HACCP、HAZOP、收益-风险分析、市场后监测报告（PMSR）、临床效果分析报告（CEA）等。这些技能将使您在竞争中脱颖而出，能够在知名医疗器械公司获得六位数的薪资。 您将熟悉全球医疗器械行业的规则、法规和标准，如ISO14971（风险管理）、ISO13485、ISO 22000、21CFR810（美国FDA）、RDC 40/2015（巴西Anvisa）、EU 2017/745 MDR、日本MHLW MO 169（PMDA）和澳大利亚TGR 2002（TGA），并能够在会议、面试及与审计员交谈时流利讨论这些内容。 课程还将讲解投诉评审、纠正和预防措施（CAPA）、过程验证（PV）、设备确认（IQ/OQ/PQ）等过程如何与风险管理相结合，以及公司为何需要进行这些活动。无论您是刚入门风险管理，还是想更新技能，亦或希望在该领域提升职业生涯，本课程都能为您提供足够的知识，使您在组织中处于前5%的行列。 此外，本课程与企业风险管理（ERM）直接相关，医疗器械和制药公司本身就是企业，因此您将学习到管理企业风险所需的所有知识。实际上，您将深入学习风险管理，这使得您能够处理任何企业的风险管理活动。本课程同样与金融风险管理（FRM）相关，详细探讨公司面临的各类风险，其中金融风险也是其中之一。因此，期望学习FRM的学生在此课程中同样能获得很大收益。
The most extensive course on Risk Management available in Udemy!This course is designed to teach you everything that you need to know to become a Subject Matter Expert (SME) in Risk Management and Quality Management System (QMS) within Medical device, pharmaceutical industry and any other enterprise that conducts risk management activity.Regardless of your current skills and experience, after taking this course, you will be comfortable communicating to experts in medical device industry about Quality management systems (QMS) and risk management (RM) standards and regulations. By the end of this course you will be a pro at creating complex Risk Assessment and Risk Measurement documents such as PFMEA, DFMEA, HACCP, HAZOP, Benefit-Risk Analysis, Post Market Surveillance Report (PMSR), Clinical Effects Analysis Report (CEA) from the scratch! Knowing this skills will set you apart from the crowd and you can easily land you six-figure jobs in a reputed medical device companies.You will be well versed in rules, regulations and standards for medical device industries across the world such as ISO14971 (Risk Management, ISO) , ISO13485, ISO 22000, 21CFR810 (FDA, USA), RDC 40/2015 (Anvisa, Brazil), EU 2017/745 MDR, MHLW MO 169 (PMDA, Japan) and TGR 2002 (TGA, Austrialia) and be able to talk about them in meetings, interviews and even with auditors.You will learn how processes like complaint reviews, Corrective and Preventative Maintenance (CAPA), Process Validation (PV), Equipment Qualification (IQ/OQ/PQ) ties into Risk Management and why companies need to do these activities.Whether you are just getting into Risk Management, or wants to freshen up your skills, or are looking to advance your career in the field, this course can provide you with more than enough knowledge to be the top 5% in your organization. Note: This course is directly related to and applies to Enterprise Risk Management (ERM). Medical device and Pharmaceutical companies are an enterprises themselves so this course teaches you everything you need to know to manage risks in an enterprise. In fact, you will learn risk management in so much in-depth from this course that you can tackle risk management activities on any enterprise.Note: This course also ties into Financial Risk Management (FRM) as we go in depth on the types of risks companies deals with, and financial risk is one of them. Hence students wanting to learn FRM can also greatly benefit from this course.
