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所在平台: Udemy |
课程主页: https://www.udemy.com/course/good-laboratory-practices/
课程评论：没有评论
课程名称: 良好实验室规范 课程概述: 本课程旨在使学员理解良好实验室规范的不同方面。首先，课程将重点讨论分析实验室和微生物实验室中的数据完整性，主要涵盖FDA/EU的引用、非IT和IT数据完整性关注领域、数据完整性的实例、检查员的当前趋势、微生物实验室的数据完整性实例等。此外，学员将学习关于数据完整性的不同指南、FDA警告信的评估与分析、ALCOA+概念的理解、数据完整性的常见实例、微生物学审计轨迹、无菌测试的重复条件等内容。 进一步地，良好实验室规范课程将指导学员进行分析方法验证、稳定性研究、异常规格和趋势调查以及分析实验室中最常见的问题解决。分析方法验证将包括FDA对分析方法的期望、QBD方法的简要介绍、实际验证的方法、质量风险管理(QRM)在分析方法验证中的角色、ICHQ14 - 分析方法开发的简要信息、ICHQ2(R1) - 分析方法验证的详细内容、验证参数的全面理解以及整体评估和重新验证标准。 课程还包括一个专门关注人类错误调查的讲座，探讨分析实验室中常见的人为错误类型，以及如何调查和避免这些错误。
This course will make you understand about different aspects of good laboratory practices. The first aspect will include data integrity in analytical laboratory and microbiolgy laboratory. This will mainly focus on FDA/EU Citations,Non IT - Focus area for data integrity, IT- Focus area for data integrity,Some examples of data integrity,Current trends of inspectors,Data integrity in Microbiology laboratories - Some examples etc. Furthermore, attendees will learn about Different guidelines on Data Integrity, Evaluation of FDA warning letter and assessment,Understanding ALCOA+ concept, Common examples of data integrity,Audit Trail in microbiology, Sterility Test - When we can repeat and many more.Further this good laboratory practices session will take you through analytical method validations, stability studies, out of specification and out of trend investigations and the most common problems solving in analytical laboratories. The analytical method validation comprises of FDA expectations about analytical method, Brief on QBD approach,How practically approach for validation,Role of QRM in analytical method validation,Brief information on ICHQ14 - Analytical method development,Detailed on ICHQ2(R1) - Analytical method validation,Understanding of all validation parameters,Overall evaluation and Revalidation criteriaThe most common problem in analytical laboratories is human error investigation. Many errors are identified as human errors. This course is having specific one lecture which will focus on learning about different types of human errors and how to investigate and avoid the human errors.
