BSI大师巡讲—医械法规课程系列.pdfVIP

BSI 大师巡讲-医械法规课程系列 全球主要法规比较课程 ISO 13485:2003/美国 QSR/加拿大 CMDRs/欧洲 MDD/ 日本JPAL 法规 全球主要法规比较课程 “医疗器械质量管理体系”:2003/美国 QSR/加拿大 CMDRs/欧洲 MDD/ 日本JPAL 法规 Course Description 课程描述 The course is designed to provide students with the knowledge to assist their companies in getting products to market more quickly in the US, Canadian, European, and Japanese markets. Personnel responsible for quality systems for medical device manufacturers will benefit from this overview course which compares the management systems of these for eign regulations with the requirements of the quality management system outlined in ”医 疗器械质量管理体 系”:2003. Students will gain knowledge of the requirements of the FDA QSR, Canadian Medical Devices Regulations, the European Medical Device Directive, and the Japanese Pharmaceutical Affairs Law to provide leadership for their organizations when placing me dical devices in foreign markets. An experienced instructor will lead participants through exercises and discussion points, including considerations in harmonizing these requirem ents and the Global Harmonization Task Force (GHTF) with respect to medical devices r egulatory requirements. 该课程将向学员讲授法规知识以辅助其公司的产品更快地进入美国、加拿大、欧洲和日本市 场。通过比较这些法规中的管理体系以及”医疗器械质量管理体系”：2003 中列明的质量管 理体系要求，医疗器械企业中负责质量体系的人员将从该课程获益。学员将获得美国 QSR， 加拿大 CMDR，欧洲 MDD 以及日本JPAL 法规的知识从而在该企业向海外市场销售产品时 起主导作用。我们的讲师将通过训练和讨论环节包括思考协调这些要求和 GHTF 的要求来 培训学员。 Learning Objectives 培训目标 On completion of this training, participants will be able to: 完成该培训时，学员将能够 1.Understand the Intent and Requirements of ”医疗器械质量管理体系”:2003 理解”医疗器械质量管理体系”：2003 的本意和要求 2.Gain an Overview of the FDA QSRl 了解 FDA QSR 的总体要求 3.Gain an Overview of the Canadian Medical Devices Regulationsl 了解加拿大 CMDR 法规的总体要求 4.Gain an Overview of the European Medical Device Directives 了解欧洲 MDD 指令的总体要求 5.Gain an Overview of the Japanese Pharmaceutical Affairs Lawl 了解日本JPAL 法规的总体要求 6.Recognize t