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所在平台: Udemy |
课程主页: https://www.udemy.com/course/pharmacovigilance-audits-and-inspections/
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**课程总结：药物警戒审计与稽查** 本课程深入探讨药物警戒（Pharmacovigilance）领域的审计与稽查，旨在帮助学员全面理解相关的原则、实践和法规，以确保药物警戒活动的质量保证。 **课程核心内容：** * **药物警戒审计及其目标：** 强调审计在确保遵守药物警戒法规和指南方面的重要性，并阐述审计的主要目的。 * **基于风险的药物警戒审计方法：** 教授如何运用风险管理策略来规划和执行药物警戒审计。 * **审计结果的行动与跟进：** 讲解如何根据审计发现采取相应的措施，并进行有效的后续跟踪。 * **质量体系与记录管理实践：** 介绍在药物警戒中至关重要的质量体系建设及规范的记录管理。 * **药物警戒稽查：目标与类型：** 阐述药物警戒稽查的目的，并区分不同的稽查类型。 * **稽查规划、范围、流程与跟进：** 详细讲解稽查的整个过程，包括规划、确定范围、执行流程及后续事宜。 * **稽查员的资质与培训：** 探讨成为一名合格稽查员所需的资质要求及相关的培训内容。 * **药物警戒稽查指标报告的审查：** 教授如何分析和解读药物警戒稽查的指标报告。 **目标学员：** 无论您是药物警戒领域的新手，还是希望提升质量保证技能的专业人士，本课程都将为您提供所需的知识和工具。 **导师资历：** 授课导师拥有超过12年在多家跨国公司（MNCs）的药物警戒领域丰富经验。 **预期成果：** 完成本课程后，您将能够自信地有效地规划、执行和报告药物警戒审计和稽查。 **立即报名，通过本课程提升您的药物警戒职业生涯！**
Welcome to the comprehensive course on Pharmacovigilance Audits and Inspections! This course is designed to provide you with a deep understanding of the principles, practices, and regulations related to quality assurance in pharmacovigilance.In this course, you will learn the importance of audits and inspections in ensuring compliance with pharmacovigilance regulations and guidelines. You will explore key topics such as:Pharmacovigilance Audit and its ObjectivesRisk-based approach to Pharmacovigilance AuditsActions based on Audit outcomes and follow-up of AuditsQuality system and Record management practicesPharmacovigilance Inspections, Objectives, TypesInspection planning, scope, process and follow-upQualification and Trainings of InspectorsReview of PV Inspection Metrics ReportWhether you are new to pharmacovigilance or looking to enhance your skills in quality assurance, this course will equip you with the knowledge and tools needed to excel in this field. The Trainer of this course have more than 12 years of Pharmacovigilance experience in different MNCs.By the end of this course, you will have the confidence to effectively plan, conduct, and report pharmacovigilance audits and inspections.Enroll now and take your pharmacovigilance career to the next level with this comprehensive course on Pharmacovigilance Audits and inspections!See you in the Class, Good Luck!!Best Regards,PV Drug Safety Academy
