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所在平台: Udemy |
课程主页: https://www.udemy.com/course/pharmaceutical-quality-system-pqs/
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课程名称：药品质量体系（PQS） 课程概述： 本课程共分为7个部分，全面涵盖了制药行业的质量管理要求与实践。 第一部分：制药行业培训策略的制定。重点介绍制药行业的培训需求和策略。 第二部分：产品质量审查（PQR）。侧重于根据ICH Q10、世卫组织、EUGMP和FDA指南进行产品质量审查的要求，内容包括： - 各个监管机构对PQR的期望 - FDA和世卫组织的具体要求 - 产品质量审查的要素 - 每个要素的实际操作方法 - 统计评估在PQR中的作用 - 实际案例帮助理解统计评估 - 欧盟与FDA之间的期望差异 - 在PQR中常见的不合规情况 此外，本部分还包括有关PQR的问答环节，帮助澄清关键要求。 第三部分：药品质量体系（PQS）。主要讲解按照ICH Q10、ISO和EUGMP指南的药品质量体系要求，内容包括： - 各种指南的理解 - ICH Q10目标 - 生命周期方法 - 管理责任 - 药品质量体系要素 - 关键要点 本部分同样设有问答环节，以帮助理解PQS的关键要求。 第四部分：变更管理系统（变更控制）。重点讨论制药行业的变更管理需求，内容包括： - 变更控制的必要性 - 不同监管机构对变更控制的期望 - 与变更控制相关的PDCA循环 - 变更控制生命周期的方法 - 变更控制的类型分类及热图应用 - 人工智能在变更控制中的作用 - cGXP计算机化系统在变更控制中的应用 - 从FDA引用中学习通常缺失的变更控制内容 第五部分：偏差管理。分析制药行业的偏差管理系统，内容涵盖： - 各监管机构对偏差的期望 - 对偏差的深刻理解 - 基于科学的偏差分类方法 - 重复偏差的分类战略 - 有效的偏差书写技巧 - 趋势分析需考虑的要点 第六部分：超出规格（OOS）和超趋势（OOT）管理。集中讨论制药行业的OOS和OOT管理，内容包括： - 监管要求 - FDA引用 - OOS的学习 - 重新取样和复测 - 异常值测试 - OOT的理解 第七部分：纠正与预防措施（CAPA）。根据Poka Yoke原理探讨CAPA，内容包括： - 指导原则要求 - 一些FDA引用 - CAPA术语的理解 - 纠正措施与预防措施的区别 - Poka-Yoke概念的理解 - Poka-Yoke的两步工作过程 - 防错措施的实施过程 - Poka-Yoke带来的好处 - 实际案例分析，包括一般性和制药行业的案例 该课程旨在为参与者提供全面的制药质量管理知识，帮助其在实际工作中有效应用。
This course consists of a total of 7 sections.Section 1 - Developing the training strategy for pharmaceuticals. This section will focus on training requirements for pharmaceuticals.Section 2 - Product Quality Review (PQR) - This section will primarily focus on product quality review or annual product quality review requirements as per ICH Q10, WHO, EUGMP, and FDA guidelines. The content of this section is as below.• Expectations about PQR from different regulatory agencies• Specific key expectations from regulatory guides (FDA, WHO)• Elements of Product Quality Review• Practical approach towards each element• Role of statistical evaluation in PQR• Practical examples for a detailed understanding of statistical evaluations• Broad Difference in expectations between EU and FDA• Common non-conformance identified in PQRIn this same section of PQR, there is one more lecture for key questions and answers related to the PQR. With this Q & A session, you will clear so many key requirements about PQRSection 3 - Pharmaceutical Quality System (PQS) - This section will primarily focus on pharmaceutical quality system requirements as per ICH Q10, ISO, and, EUGMP guidelines. The content of this section is as below.• Understanding the different guidelines• ICH Q10 Objectives• Life Cycle Approach• Management Responsibility• Elements of Pharmaceutical Quality System• Key messageIn this same section of PQS, there is one more lecture for key questions and answers related to the PQS. With this Q & A session, you will clear so many key requirements about PQSSection 4-Change Management System (Change Control) - This section focuses on the change management system followed in the pharmaceutical industries. The content of this section is as below.• Need for Change Control• Guideline expectations about change controls EU, FDA, ICH, PIC/S, ISO, etc.• PDCA Cycle in relation to Change controls• Change Control Life cycle approach• Types of change controls - Categorization using Heat Matrix• Artificial Intelligence - Scope in Change Control• cGXP Computerized systems - Scope in Change Control• Normally missing in Change Controls learn from FDA citationsSection 5 -Deviation management - This section focused on the deviation management system followed in the pharmaceutical industries. The content of this section is as below.• Guideline expectations about deviations- EU, FDA, ICH, ANVISA, ISO, etc.• Detailed understanding of deviations• Scientific way for categorization of deviations -Simplified risk assessment tool in line with WHO recommendations• Categorization strategy for repeat deviations• Effective writing of deviations• Trending - Points need to considerSection 6- Out-of-specification (OOS) and Out-of-trend (OOT) management - This section focused on the out-of-specification and out-of-trend management followed in the pharmaceutical industries. The content of this section is as below.• Regulatory requirements• FDA Citations• Learning about OOS• Resampling and Retesting• Outlier Tests• Understanding of OOTSection 7-Corrective and preventive actions (CAPA) - This section focused on the Corrective and preventive actions in line with the Poka Yoke Principle. The content of this section is as below.• Guideline Requirements• Some FDA Citations• Understanding of the CAPA terminology• Corrective Vs Preventive Actions• Understanding Poka-Yoke Concept• The Poka-Yoke 2-step working process• Process of mistake-proof actions• Benefits of Poka -Yoke• Examples- General as well as pharmaceutical
