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所在平台: Udemy |
课程主页: https://www.udemy.com/course/process-validation-essentials-for-quality-assurance-v/
课程评论：没有评论
课程名称：过程验证：质量保证的基础 课程概述：过程验证：质量保证的基础是一门集中于实践的课程，将（FDA PV指导、EU GMP附录15、ISO 13485、ICH Q9/Q10）验证理论转化为日常生产中的实际应用。在为期三天的紧凑课程中，学员将构建、执行并辩护一个满足监管机构要求并保护患者的生命周期验证计划。课程内容包括：全球框架；三阶段生命周期——过程设计、过程验证、持续过程验证；基于风险的规划文件（URS、VMP、协议、报告）；数据完整性控制（ALCOA+）；统计工具如Cp/Cpk、控制图和警报/行动限值；以及符合第11部分要求的数字验证MES、历史记录和AI监测。 学习成果：学员将能够起草合规的验证主计划，撰写风险优先的PPQ协议，解读能力指数，设定有效的监测限值，将CPV输出整合进CAPA和管理审查，并以自信的态度向审计员解释决策。 课程形式：课程由互动讲座、分组模拟和一个团队项目（为模拟产品创建PPQ协议）组成。参与者将获得可编辑的模板、统计计算器以及90天的在线后续支持。 目标受众：质量保证/质量控制人员、过程工程师、验证专家和准备接受FDA、MDSAP或EU检查的监管专业人员。完成该课程后，学员将获得21小时的证书，可用于ASQ、ISPE或RAPS的继续教育学分。该课程结合理论、实践计算练习和真实的检查案例故事，以有效巩固学习效果。
Process-Validation: Essentials for Quality Assurance is a focused, practice-based course that turns (FDA PV Guidance, EU GMP Annex 15, ISO 13485, ICH Q9/Q10) validation theory into everyday plant reality. Over three intensive sessions you will build, execute, and defend a lifecycle validation program that satisfies regulators and protects patients.Topics include: global frameworks; the three-stage lifecycle-Process Design, Process Qualification, Continued Process Verification; risk-based planning documents (URS, VMP, protocols, reports); data-integrity controls (ALCOA+); statistical tools such as Cp/Cpk, control charts, and alert/action limits; and digital validation with Part 11-compliant MES, historian, and AI monitoring.Learning outcomes: draft a compliant Validation Master Plan, write risk-ranked PPQ protocols, interpret capability indices, set meaningful monitoring limits, integrate CPV outputs into CAPA and management review, and explain decisions to auditors with confidence.Format: interactive lectures, breakout simulations, and a capstone team project creating a PPQ protocol for a mock product. Participants receive editable templates, statistical calculators, and 90-day post-course online support.Target audience: QA/QC staff, process engineers, validation specialists, and regulatory professionals preparing for FDA, MDSAP, or EU inspections. Completion earns a 21-hour certificate suitable for ASQ, ISPE, or RAPS continuing-education credit. The course blends theory, hands-on calculation exercises, and real inspection stories to reinforce learning effectively.
