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所在平台: Udemy |
课程主页: https://www.udemy.com/course/current-good-manufacturing-practices-cgmp-in-pharma/
课程评论：没有评论
课程名称：制药领域的当前良好生产规范（cGMP） 课程概述：根据FDA的指导，所有参与药品制造、处理、包装或贮存的人员都需具备教育、培训和经验，以便能够有效执行分配的职能。培训内容应包括员工所从事的特定操作及当前的良好生产规范（GMP）。根据欧盟的指导，制造商应为所有进入生产和存储区域或控制实验室的人员提供培训，包括技术、维护和清洁人员，以及其他可能影响产品质量的人员。新招聘的员工应接受与其职责相符的培训，以掌握质量管理体系和良好生产规范的理论与实践。本课程特别设计以符合不同监管要求。 该培训项目包含13节讲座，涵盖GMP的各个方面，包括培训要求、质量风险管理、针对cGXP计算机系统的检查准备、21 CFR第210和211部分及电子CFR的概念、通过21步方法建立质量文化以及如何在组织中建立质量文化、良好的GMP培训行为等。还特别讨论了药品质量体系的重要性。此外，课程中还包括FDA的质量管理成熟度（QMM）计划、趋势评估以及偏差、变更控制与CAPA（纠正和预防措施）的相关主题，所有这些内容均通过录制的课程提供。 此培训将涵盖完整的cGMP要求，时长约为12小时。如有任何问题或需澄清之处，请在评论区提出，我会及时回复。
As per FDA guide, (a) Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions.Training shall be in the particular operations that the employee performs and in current good manufacturing practice.As per EU guide, The manufacturer should provide training for all the personnel whose duties take them into production and storage areas or into control laboratories (including the technical, maintenance and cleaning personnel), and for other personnel whose activities could affect the quality of the product.Besides the basic training on the theory and practice of the quality management system and Good Manufacturing Practice, newly recruited personnel should receive training appropriate to the duties assigned to them.This training program is uniquely designed to comply the different regulatory expectations.This program comprise of total 13 lectures. Which touches all the parts of GMPs like - Training requirements, Quality Risk management, inspection readyness for cGXP computerised systems, 21 CFR Part 210 and 211 with eCFR concept, Building quality culture with 21 steps appraoch and further how to establish the quality culture in the organisation, Good behavioural aspect of GMP training, Pharmaceutical quality system is very important when we discuss about the GMP training.Further there are other topics with recorded sessions which includes - Quality management maturity (QMM) program by FDA, Most of the personnel prepares the trend but could not evaluate correctly. So, one topic is on evaluation of the trends.After that there is separate topcis with recorded sessions on deviation, change control and CAPA.This training session will cover complete cGMP requirements in about 12 hours of the lectures. Further more, if you have any question/s or need any clarification/s, please put your questions in comment section. I will respond you.
