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所在平台: Udemy |
课程主页: https://www.udemy.com/course/product-quality-review-annual-product-quality-review/
课程评论：没有评论
课程概述：年度产品质量审查（Product Quality Review）是一项与质量管理体系要求相关的重要课程。该课程分为几个讲座，帮助学员系统地了解与产品质量审查相关的重要概念和实践。 第一讲：流程能力与流程能力指数。此讲座旨在帮助学员清晰地理解这些概念，因为在产品质量审查中，需要对其进行评估。 第二讲：制药质量体系。讲座内容包括主题的重要性、课程议程、讲师介绍、相关指南的理解、国际会议协调会Q10的目标、生命周期方法、管理责任、制药质量体系的要素以及传递的关键信息。 第三讲：与产品质量审查相关的关键问题。通过本讲座，参与者可以清晰概念，避免未来出现错误。 第四讲：产品质量审查的详细讨论。内容包括来自不同监管机构对PQR的期待、具体的监管指南（FDA、WHO）的期望、产品质量审查的要素、每个要素的实际应用、统计评估在PQR中的作用、统计评估的实际案例、欧盟与FDA期望的广泛差异以及在PQR中常见的不合规情况。 最后一讲：持续过程验证。许多人认为持续过程验证与PQR是相同的，但实际上两者是不同的。 本课程特别适合希望深入理解制药行业产品质量审查过程的专业人士。
The Product Quality Review is part of the Quality management system requirements.The first lecture is related to process capability and process capability index. This will help viewers to understand this concept very clearly because as a part of PQR, it is required to evaluate.The second lecture is on Pharmaceutical Quality system. This lecture constitutes below discussion•Importance of topic and Agenda•Know your Trainer•Understanding the different guidelines•ICH Q10 Objectives•Life Cycle Approach•Management Responsibility•Elements of Pharmaceutical Quality System•Key messageThe third lecture is on Key questions related to PQR. Due this this lecture, the participants will clear their concepts and avoid errors in future.The fourth lecture is on Product Quality Review. The lecture will discuss in detail about PQR expectations. This session includes below points - •Importance of topic & Know your Trainer•Expectations about PQR from different regulatory agencies•Specific key expectations from regulatory guides (FDA,WHO)•Elements of product Quality Review•Practical approach towards each elements•Role of statistical evaluation in PQR•Practical examples for detailed understanding about statistical evaluations•Broad Difference in expectations between EU and FDA•Common non conformance identified in PQRThe last lecture is on continued process verification. Many people think that, continued process verification and PQR are same. But both are different.
