风险管理的SOP实例非洲经委会课程的GMP医疗的所有代表Risk Management SOP Example...

清歌一曲月如霜

医药产品制造商德国协会（Bundesverband德医药有限公司，Hersteller - BAH）的规定，即更新其成员公司配套文件样本对于GMP的申请。这些示例文件是非常有用的，主要是针对医药产品的生产厂家。然而，也有样品的SOP的医疗器械。风险分析上市产品的结果是医疗器械的技术文件的重要组成部分。在这方面，风险评估是在医疗设备的生命的重要组成部分。其中一个可能性进行风险分析是FMEA。对于风险评估的这种方法，BAH发布了（7页）风险管理的SOP“A FMEA的性能”，用实际的例子有10页的FMEA表格的例子。
您是否有兴趣在这个SOP和相关表格？这些文件主要在德语。然而，随着2014年10月在非洲经委会课程“GMP医疗器械”，从1-2德国海德堡的代表，您将收到英文这些样本文件免费的附加组件。


The German Association of Medicinal Product Manufacturers (Bundesverband der Arzneimittel-Hersteller - BAH) provides i.e. updates for its member companies supporting sample documents with regard to GMP applications. These sample documents are very useful and are primarily aimed at manufacturers of medicinal products. Yet, there are also sample SOPs for medical devices. Results of the risk analysis for marketed products are an essential part of the technical documentation of medical devices. In this respect, risk assessment is a crucial component in a medical device's life. One of the possibilities to perform a risk analysis is the FMEA. For this method of risk assessment, the BAH has released an example of a risk management SOP "Performance of a FMEA" (7 pages) and a 10-page FMEA form with a practical example.
Are you interested in this SOP and the associated form? The documents are mainly in German language. Yet, as a delegate of the ECA Course "GMP for Medical Devices" from 1-2 October 2014 in Heidelberg, Germany, you will receive these sample documents in English as free add-ons.

清歌一曲月如霜

谷歌翻译，对付着看吧，

幻影

。。。凑合看。