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所在平台: Udemy |
课程主页: https://www.udemy.com/course/know-the-usfda/
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课程总结：美国FDA程序与引用的简要理解 本课程“美国FDA程序与引用的简要理解”旨在深入探讨与美国食品药品监督管理局（FDA）相关的培训和合规性要求。课程内容包括： 1. **FDA警告信示例**：通过具体案例分析FDA关于培训的警告信，帮助学员理解警告信的内容和影响。 2. **培训的重要性**：通过简单的示例说明培训在符合FDA标准中的关键作用。 3. **监管期望**：解读欧盟、美国FDA和世界卫生组织（WHO）对培训的监管期望。 4. **如何满足期望**：提供满足这些监管期望的策略和建议。 接下来的讲座将介绍FDA 483表格和警告信的相关主题，包括： - 可能的监管或执法途径 - FDA 483表格的定义及其重要性 - 在闭幕讨论和FDA 483审查期间应采取的措施 - 如何对FDA 483表格的后续行动作出响应 - 对警告信的理解及其颁发的考虑因素 - 响应警告信的时间框架与审核过程 另外，课程还将教授如何对FDA草案指南提交评论，具体内容包括： - 主题的介绍及概述 - 指南文件的类型 - 如何提交评论和建议 - CDRH指南的提交格式 - 常见问题解答及致谢 最后一讲关注FDA发布的白皮书，讨论FDA药品评估与研究中心（CDER）建立的质量管理成熟度（QMM）计划。CDER正在制定质量管理成熟度评估工具，以评估药品制造企业如何有效监测和管理质量及质量系统，促进制造商实施超越当前良好生产规范（CGMP）要求的质量管理实践。 通过本课程，学员将全面了解FDA的程序要求及合规性知识，有助于更好地应对行业挑战。
This training video will provide insight on 1. Some examples of FDA warning letters about training 2. Why training is important? This will be explained with a small example. 3. The regulatory expectations from the training - EU, USFDA, and WHO 4. How to comply with these all expectations and many more.The next lecture will help you to understand many topics related to FDA Form 483 and Warning Letter - Understanding FDA Procedure. Below points are discussed during this session - Possible Regulatory or Enforcement Pathways What is a Form FDA 483? What should I do during the closing discussion and Form FDA 483 review? Post FDA 483 - How to Respond? What Should Your Response Include? Understanding of warning letter. Issuing Warning Letters - Factors to Consider by FDA Purpose of issuing a warning letter Ongoing or Promised Corrective Actions Response Letter Verification of Corrective Actions Multiple Centre Review Warning Letters Response - Time FrameThe other lecture with help you with how to submit comments on DRAFT FDA Guidelines. The content of the session is below; Introduction and overview of the topic.Types of Guideline Documents How to Submit Comments? Suggestions for Commenting Submitting comments on CDRH Guidelines Recommended format by CDRH References Q & A AND Vote of Thanks. The last lecture is based on the white paper issued by the FDA. FDA's Center for Drug Evaluation and Research (CDER) is establishing a program to promote quality management maturity (QMM) at drug manufacturing establishments. CDER is developing its QMM Assessment Tool (protocol and rubric) to evaluate how effectively establishments monitor and manage quality and quality systems. The QMM program aims to encourage drug manufacturers to implement quality management practices that go beyond current good manufacturing practice (CGMP) requirements.
