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所在平台: Udemy |
课程主页: https://www.udemy.com/course/process-validation-for-pharmaceutical-industries/
课程评论：没有评论
**课程名称：制药行业工艺验证** **课程概述：** 本课程旨在帮助制药行业的专业人士深入理解并掌握工艺验证的关键概念和实践。在GMP合规日益重要的今天，工艺验证是提升生产单位技术和财务实力的核心。 Auditors、监管机构以及内部审核员都高度关注“验证”，它是制药行业所有系统和流程的基石。本课程针对传统工艺验证方法中存在的不足，结合监管指南的期望，提供全面的讲解和解决方案。 **课程内容：** * **第一部分：工艺设计（Stage 1 Process Design）** * 深入讲解如何在工艺验证的“工艺设计”阶段进行实施。 * **第二部分：验证主计划（Validation Master Plan - VMP）** * **指南要求：** 涵盖欧盟（EU）、美国食品药品监督管理局（FDA）等主要监管机构的要求。 * **FDA验证指南：** 详细解读FDA的验证指南。 * **VMP的七个关键要素：** 详细阐述VMP的七个核心组成部分。 * **VMP要素详解：** 对VMP的各项要素进行深入的讨论。 * **常见错误：** 指出在制定和执行VMP过程中常见的错误。 * **第三部分：详细工艺验证要求** * **不同指南的期望：** 理解并比较欧盟、FDA、Anvisa、TGA、WHO等不同监管机构的指南要求。 * **通用的监管期望：** 总结普遍适用的监管期望。 * **传统方法与混合方法：** 对比分析传统工艺验证方法与混合方法的优劣。 * **关键工艺参数（CPP）和关键质量属性（CQA）：** 明确CQA和CPP的概念及其在验证中的重要性。 * **工艺验证中缺漏之处：** 指出在实际工艺验证中通常会被忽略的环节。 * **同期验证方法：** 讲解并分析同期验证的实施。 * **持续工艺验证（Continued Process Verification） vs. 产品质量回顾（Product Quality Review）：** 区分并阐述两者。 * **设计工艺验证方案/报告：** 提供设计工艺验证方案和报告的指导。 * **欧盟与FDA指南的详细差异：** 深入剖析欧盟和FDA指南在工艺验证方面的具体区别。 * **第四部分：工艺验证第三阶段要求（Stage III Process Validation）** * **持续工艺验证：** 重点讲解“持续工艺验证”的实施。 * **指南要求：** 涵盖欧盟、FDA、WHO等机构的相关要求。 * **FDA对持续工艺验证的期望：** 详细了解FDA在此方面的具体期望。 * **取样考虑：** 探讨在持续工艺验证中的取样策略。 * **实施的实践视角：** 提供实施持续工艺验证的要点和注意事项。 * **欧盟与FDA的差异：** 再次强调在持续工艺验证方面的欧盟与FDA差异。 * **从警告信中学习：** 通过分析警告信中的案例，吸取经验教训。 * **第五部分：关键问题与澄清** * 本部分通过两个视频讲座，解决与工艺验证相关的关键问题，并符合监管指南的要求，进一步加深学员理解。
The most crucial factor to achieve Business Growth in Pharma manufacturing nowadays, is Compliance with GMP norms, to increase the technical and financial strength of Manufacturing units. Currently, the aspect focused on by most Auditors, both internal, as well as external including regulators, is "Validation", which is the key to all systems and processes in the pharmaceutical industry.As such, there are many open threads in the Traditional Process Validation approach, which need to be discussed, explained, and closed with the help of understanding the expectations of different Regulatory guidelines.The course has multiple sections.Section 1 is for stage 1 of the process validation which is "process design". It explains how to implement the process design stage in the process validation.Section 2 is for the "Validation Master plan". This section elaborates on the following;•Guideline Requirements - EU, FDA•Validation Guidance by FDA•7 Key Elements of VMP•VMP elements discussion in detail•Common ErrorsSection 3 is for the Detailed "process validation" requirements. The session includes;•Understanding different guideline expectations - EU, FDA, ANVISA, TGA, WHO, etc.•Common regulatory expectations•Traditional approach and Hybrid approach, CQA and CPP•What is normally missing in process validation•Concurrent validation approach•Continued process verification vs product Quality Review•Designing process validation protocol/Report•Detailed difference between EU and FDA guideSection 4 is for the "Stage -III Process Validation" Requirements. That means it elaborates on "continued process verification". This session includes;•Guideline Requirements - EU,FDA, WHO•Understanding the FDA expectations about the Continued process verification•Sampling Considerations•Practical view to implement - Points to consider•Difference between EU and FDA•Learning from Warning LettersSection 5 is for the key questions and clarifications related to process validation requirements. In this section two video lectures are available. Which will clear further key questions in line with regulatory guideline requirements.
