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所在平台: Udemy |
课程主页: https://www.udemy.com/course/investigator-qualification-for-pharmaceuticals/
课程评论：没有评论
课程名称：制药领域的调查执行 概述：本视频将帮助观众理解调查过程培训的必要性，同时简要介绍各种调查工具及如何通过记录特定调查工具的使用来实现合规性。此外，观众还将了解到一些人在调查过程中常见的错误。接下来的一节课将会讲解超出规格（OOS）结果、FDA对OOS调查的要求、第一阶段和第二阶段的调查，以及一些FDA的列举案例、OOS的常见问题、异常值测试、重测和重新取样的考虑因素，以及有关三西格玛和六西格玛的实际例子，以便对趋势偏差进行评估。 随后的一节课将使你理解人为错误的后果，如何调查人为错误，以及减少人为错误的方法。此环节将讨论如瑞士奶酪模型和四象限模型等不同的研究模型。接下来的一节课将帮助你了解良好审查实践。此培训将包括一些FDA的列举案例、监管对审查的期望、良好审查实践的十项关键原则、如何评估审查员的资格等内容。 最后，我们将呈现一个小视频讲解质量风险管理原则，简要阐述其实施的简便性及如何达到合规水平，并用简单的例子进行说明。
This video will help viewers to understand why training on the investigation process is required. Further, you will understand in brief about types of investigation tools and how to achieve compliance by recording the use of specific investigation tool/s. Also, the viewers will understand the common errors by some persons during the investigation.The next lecture will help to understand about out- of specification(OOS) results, FDA requirements for OOS investigation, Phase 1 and Phase 2 investigations, some examples of FDA citations, common problems of OOS, Outlier tests, Retesting and Resampling considerations, and Practical examples of three sigma and six sigma for Out of trend evaluationThis next lecture will take you through understanding the consequences of Human errors, how to investigate human errors, and furthermore, the ways to reduce human errors. During this session, different models like the Swiss cheese model, and four quadrant models also will be discussed.The next lecture will help you to learn about Good Review practices. This training will include, some examples of FDA citations, regulatory expectations about the review, 10 key principles about good review practices, how to qualify reviewers, and many more.There is a small video lecture that will help viewers to understand Quality Risk Management principles, how it is simple and easy to implement, and achieve the compliance level. We have explained this with simple examples.
