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所在平台: Udemy |
课程主页: https://www.udemy.com/course/manufacturing-site-registration/
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课程名称：制造现场注册硕士课程 概述：本课程是任何药品或医疗器械注册的基础，尤其是与各国卫生主管部门的注册有关。在注册任何医疗产品时，其制造现场必须与相关的卫生主管部门进行注册。此课程将探讨产品和制造现场的档案如何同时提交至目标国家的卫生主管部门进行注册。 您将学习到的内容包括： - 现场注册介绍 - 现场提交档案 - 现场提交检查清单 - 现场申请表 - SMF（现场管理文件）验证 - 现场审计 - CAPA（纠正和预防措施） - 续期管理 本课程是各国法规事务专业人士的核心基础。我们将一起探索什么是制造现场？制造现场的潜在可能性和不同的商业模式是什么？制造现场如何与生产商和 MAH（市场授权持有人）在文件上相关联？如何准备现场提交的档案？SMF是什么，以及如何准备它。 SMF是现场档案提交中的核心文件，我们将详细研究这个文件及其附录，每个附录与SMF的哪个部分相关： - 附录I：授权法令 - 附录II：药品和原料药清单 - 附录III：GMP证书 - 附录IV：分包商清单 - 附录V：组织结构图、职责和简历 - 附录VI：布局图 - 附录VII：示意图 - 附录VIII：设备清单、FP、API、CQ 最后，我们将总结注册检查清单、现场布局和不同国家的表格，并探讨SMP和其验证。我们还将处理现场审计的主题，了解审计的合规性，及如果审计结果存在问题，我们如何进行CAPA的提升、执行和关闭。 这门独特的课程由制药学院提供，课程主题在面试中常被提及。让我们在法规事务专业中建立我们的核心知识体系，打牢我们的基础。
This course is the backbone for any product registration, either pharmaceutical or medical device product with any health authority ever in the country, to register any healthcare product, the manufacturing site of this product must be registered as well with the relevant targeted health authority, the dossiers of both the site and the product go parallel to each other as one submission to the required health authority in the targeted country for the registration.What will you learn?Introduction Site Registration Letters Site submission dossier Siet submission checklist Site Application Forms SMP Validation Site Audit CAPA RenewalThis course is the core and the base for the regulatory affairs professionals in all countries.In this course, we will explore together, what is the site? what are the probabilities of a site? what are the different most common business models? and how the site is related to both manufacturer and MAH document-wise? How to prepare the dossier for the site submission? What is the SMF? and how to prepare it.The SMF, which is the core document in the site dossier submission, we will study it in detail along with its annexes, each annex is concerning which section of the SMF.Annex I Decrees AuthorizationAnnex II List of Medicinal Products and APIsAnnex III GMP CertificatesAnnex IV List of Subcontractors Annex V Organization Chart, Duties, CVsAnnex VI Layout Annex VII Schematic DrowningsAnnex VIII Equipment's list, FP, API, CQThen we will sum up our course with the registration Checklists, site layouts, and forms of different countries and finally, the SMP and its validation Then we will handle the topic of the Site Audit at a glance, along with its probabilities, either complied or if the Audit resulted in findings so in this case, we have to raise and run CAPA So we will close our course with the CAPA "raise, run, and close CAPA". This unique course comes to you from the Pharma Academy from practice.This course topic has always been on the table during interviews. Let us build up our backbone in the regulatory affairs profession, let us build up our core dossier
