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所在平台: Udemy |
课程主页: https://www.udemy.com/course/gmp-aspects-of-warehouse-storage-areas-in-pharmaceuticals/
课程评论：没有评论
**课程名称：** 药品良好仓储规范 **课程概述：** 本课程旨在提供全面的药品良好仓储规范培训，以应对监管机构检查的重点——仓库和储存设施。通过本培训，您将深入了解GMP（药品生产质量管理规范）以及优于GMP的“最佳生产实践”。课程内容基于FDA、EUGMP、WHO、ANVISA、PIC/S、TGA及Schedule-M等权威机构的要求，特别关注仓库的各个环节，包括物料的接收、储存、发放、核销，以及印刷包装材料、一级包装材料、活性和非活性物料的特定储存要求。 **课程第一部分重点：** * 仓库和储存设施的合规性。 * GMP基础培训在仓储领域的重要性。 * 良好制造实践与最佳制造实践的区别。 * 物料接收、储存、发放、核销等全过程的良好仓储实践。 * 印刷包装材料、一级包装材料、活性和非活性物料的特定储存要求。 **课程第二部分重点：** * 对第一部分内容的简要回顾。 * 抽样和检测要求。 * 抽样和检测过程中的注意事项。 * 复检要求。 * 称量区域的要求。 * 成品处理。 * 发货和运输。 * 召回和退货管理。 本课程通过短视频和详细讲座形式呈现，旨在帮助您掌握药品良好仓储规范，并通过Udemy获得相关认证。如果您有任何疑问，欢迎在评论区提出，讲师将一一解答。
Most of all regulatory inspections starts with Warehouse/storage facilities. To ensure first good impression and long lasting impression, it is very important to pay compliance attention to this area. Also, as a part of basic GMP(Good Manufacturing Practices) training requirement, all the persons working in the area should be trained on GMP. So, this session will help you all to get trained about good warehouse practices followed by certification from Udemy. With this training session, you will learn about difference between Good Manufacturing Practices and BEST Manufacturing Practices. Further short learning videos and detailed lecture on good warehouse practices. These lectures are made on the basis of requirements of FDA, EUGMP,WHO, ANVISA, PIC/S,TGA &Schedule-M. This training session will specially focus on all aspects about warehouse. For example, receipt of materials, storage of materials, issuance of materials, reconciliation of materials and many more. Furthermore, wherever required, specifics for printing packing materials, primary packing materials, active materials and inactive materials is discussed. The good warehouse practices session 2 will specifically covers Brief recap on session-1 of this subject,Sampling & Testing requirements,Precautions during sampling and testing,Retesting requirements,Requirements for weighing areas, Finished product handling, Dispatch and Transportation, Brief about Recall and Return goods.If you have any questions, please feel free to put in comment section. I will revert with your all queries.
