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所在平台: Udemy |
课程主页: https://www.udemy.com/course/data-integrity-requirements-for-pharmaceuticals/
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课程名称：制药行业的数据完整性要求 课程概述：数据完整性是良好生产规范（GMP）的基本原则之一。在过去三年中，FDA和欧洲检查员报告了多起数据完整性相关的违规行为。许多美国警告信和欧盟不合规报告针对严重的数据完整性违规问题。数据完整性问题一直是GMP检查的重点，且将持续受到关注。因此，国际机构（如FDA、EMA、PIC/S、WHO和MHRA）发布了草案和最终文件，以描述对数据完整性的监管期望。尽管所有指导原则并不打算对受监管公司施加额外的监管负担，但制药行业在如何将这些要求落实到日常业务中仍存在很多不确定性。 学习目标包括了解制药组织及合同实验室中GMP监管实验室的数据完整性要求，以及实验室人员如何确保合规并能够捍卫自己的立场。第二人审核是关键过程，需全面有效以确保及时发现和解决数据问题。因此，本课程旨在帮助学生理解数据完整性和审计跟踪审查的基础知识，同时区分良好文档实践要求与数据完整性要求之间的细微差别。课程特设专门环节，重点探讨分析实验室和微生物实验室的数据完整性要求。需要注意的是，本课程仅关注混合和电子系统，不涉及纸质数据的完整性。
Data Integrity is one of the basic GMP principles since years multiple Data Integrity citations were reported by FDA und European inspectors during the last 3 years. Many US Warning Letters and EU Non-Compliance Reports deal with serious Data Integrity violations. Data Integrity questions have been and will continue to be the focus of many GMP inspections. As a consequence international authorities - FDA, EMA, PIC/S, WHO, MHRA - published draft and final documents to describe the regulatory expectations of Data Integrity. Although all guidelines are not intended to impose additional regulatory burden to the regulated companies, a lot of uncertainty predominates the pharmaceutical industry how to implement these requirements into the daily business. The learning objectives are firstly, understand the data integrity requirements of a GMP regulated laboratory in pharmaceutical organisations and contract labs and secondly, how laboratory personnel can ensure compliance and be able to defend their positions. Second person review is a critical process that needs to be thorough and effective to ensure that data issues are picked up and resolved. Hence, this course is designed in such a way that, the students will understand basics in data integrity and audit trail review, further they will understand very small difference between good documentation Practices requirements and data integrity requirements. There is specialised session to focus the data integrity requirements for analytical laboratories and Microbiology laboratories.Note that this course will focus only on hybrid and electronic systems and will not consider paper-based data integrity.
