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所在平台: Udemy |
课程主页: https://www.udemy.com/course/course-on-current-good-manufacturing-practices-for-pharma/
课程评论：没有评论
课程名称：制药领域的先进良好生产规范（GMP） 课程概述：本课程旨在帮助学习者深入理解先进的良好生产规范。课程特别关注以下几个方面：良好的仓储实践、良好的实验室实践、良好的计算机系统以及良好的数据完整性实践。此外，课程还将讨论良好的文档实践和审查实践。在课程开发过程中，良好行为的实践也被特别强调，因为确保数据完整性和良好的生产规范首先需要良好的行为。课程中将特别针对分析实验室和微生物实验室的数据完整性方面进行讲解。 课程将涵盖以下几个主题： - 制药行业的调查、超限（OOS）、超限（OOT）问题 - 制药稳定性研究 - 对不同方面GMP的指导期望 - FDA引用情况 - 计算机系统合规性，包括FDA第11部分、业务连续性计划和Excel电子表格验证 - 如何为检查做好准备，重点讨论计算机系统的要求 整体而言，这是一门全面的制药课程，涵盖多个学科。课程包含多节录制的讲座，学习者需要专注于每一节讲座，以更好地理解内容。如有任何问题，请在评论区提问，我会及时回复。
This course will help learners to understand advanced good manufacturing practices. This course is prepared with special attention on good warehouse practices, good laboratory practices, good computerized systems, and good data integrity practices. Further, this course will discuss good documentation practices and good review practices also. Further emphasis will be on Good behavior practices are also considered while developing this course. As Good behavior will first be required to ensure data integrity and good manufacturing practices. This course will further specifically have lectures on data integrity aspects of analytical laboratories and microbiology laboratories.This course has many lectures. Below different points will be discussed in the lecturesInvestigations, OOS, OOT in pharmaceuticals, stability study in pharmaceuticals, guideline expectations about different aspects of GMP, FDA citations, the computerized system compliance includes - FDA part 11, business continuity plan, and excel spreadsheet validation also.How you can be ready for inspection is also discussed with a special focus on computerized system requirements. Overall, this is the complete course for learning pharmaceuticals in all disciplines. This course contains many recorded lectures. Kindly request you fully focus on each lecture to understand it in a better way.Further, if you have any question/s, please put your questions in the comment section. I will respond to your questions.
