MDR Article 83.4和CAPA直接有关. “If, in the course of the post-market surveillance, a need for preventive orcorrective action or both is identified, the manufacturer shall implement the appropriate measures and inform the competent authorities concerned and, where applicable, the notified body. Wh...
•Correctiveactionandpreventiveaction(CAPA)system. 纠正行动和预防行动(CAPA)系统 •Changemanagementsystem. 变更管理系统 •Managementreviewofprocessperformanceandproduct quality 工艺性能和产品质量管理审核 PDF文件使用"pdfFactoryPro"试用版本创建.fineprint.cn •Section3.2.2CorrectiveActionandPreventive Action(CA...
ISPE APQ指南-纠正措施和预防措施(CAPA)系统Corrective Action and Preventive Action(CAPA) System-2020(中文版) 下载积分: 1000 内容提示: 文档格式:PDF | 页数:136 | 浏览次数:138 | 上传日期:2022-11-29 15:47:00 | 文档星级: 阅读了该文档的用户还阅读了这些文档 7 p. HJ 1410.13-2025 水生...
CAPA 纠正预防行动Corrective and Preventive Action精选.pdf,Pharmaceutical Services Corporation 美国医 服务有限公司 Corrective and Preventive Action 纠正预防行动 PDF 文件使用 pdfFactory Pro 试用版本创建 Definition 定义 CORRECTIVE ACTION Putting out a fire
CAPA Plan-Corrective and Preventive Action 热度: Corrective and Preventive Action Control Procedure纠正及预防措施控制程序 A1 热度: [Company Name] [Company Group, Division, Location] Document Title: Corrective and Preventive Action Document Number: [Document Number] ...
QAdvancingPharmaceuticalQualityISPEQualityManagementMatur1tyProgramGUIDE:CorrectiveActionandPreventiveActionCAPASystem
CAPA 是纠正措施和预防措施 (CAPA) 的缩写。MDR 的第2条对 CAPA 的定义进行了阐述。“上市后监督”指的是制造商与其他经济运营商合作，系统地收集和审查他们投放市场的设备所获得的经验，以便主动识别任何需要立即采取必要的纠正或预防措施的情况。“纠正措施”是指为消除潜在或实际的不合格或其他不良...
An effective corrective action preventive action plan requires a high level of accuracy and flexibility. Because of the rigorous regulatory requirements that exist in the life science industries, implementing an efficient CAPA plan sooner rather than later is recommend to avoid regulatory discipline. The...
CAPA 纠正预防行动Corrective and Preventive Action 热度: CAPA Plan-Corrective and Preventive Action 热度: Corrective and Preventive Action Control Procedure纠正及预防措施控制程序 A1 热度: 相关推荐 1 CorrectiveandPreventiveAction JayJariwala OfficeofCompliance CenterforDevicesandRadiologicalHealth U.S....
aTo delineate a procedure for Corrective Action and Preventive action (CAPA) program in executing and documenting activities for continued compliance and improvements in processes. 描述一个做法为惩治行为和预防措施(CAPA)节目 执行和提供活动为持续的服从和改善 过程。[translate]...