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【南京】2026药企生产设施设备预防性维护和高效维修

  • 2026-03-21 12:50:15
【南京】2026药企生产设施设备预防性维护和高效维修

组织单位

中国化工企业管理协会医药化工专业委员会
药成材培训在线直播平台

各有关单位

   在药品生产质量管理的核心体系中,生产设备的可靠运行与科学维护绝非简单的后勤保障,而是直接决定产品质量、生产合规性与运营效益的生命线。随着药品监管趋严、市场竞争加剧以及“精益生产”理念的深入,制药企业的设备管理正面临前所未有的挑战:如何超越传统的“坏了再修”模式,构建一个前瞻性、体系化且完全符合GMP规范的现代化维保体系,已成为企业保障供应、控制成本、顺利通过各类审计的关键。当前,众多制药企业在生产设备维保实践中普遍存在显著痛点:一是“合规性挑战”,维保活动缺乏基于风险的策略,记录不规范,难以有效应对监管机构对设备确认、变更控制及数据完整性的严苛审查;二是“效能瓶颈”,预防性维护计划流于形式或过度维护,紧急故障仍频发,导致生产中断、成本攀升;三是“管理脱节”,生产、设备、质量部门协作不畅,维保信息孤岛化,难以支持科学决策;。为帮助医药企业破解痛点、补齐能力短板,精准对接行业发展需求与监管要求,我单位将于2026年4月24日-26日在南京举办“2026药企生产设施设备预防性维护和高效维修专题培训班”。详细通知如下:

会议安排

会议地点:南京市(具体地点通知给已报名人员)
会议时间:2026年4月24日-26日(24日全天报到)
培训结束后,学员可登录协会系统官网查看或下载培训证书。

主要交流内容

一)药厂设施设备管理国内外cGMP要求概述

1、新版GMP对设备生命周期要求
1.1、近年来国内认证常见问题分析
2、FDA及欧盟法规对设备管理要求
3、ISPE设备及公用系统相关法规
4、ICH Q9风险管理在设备生命周期中的应用
二)宏观规划设施设备的维护维修管理
1、设备设施生命周期全过程如何通过文件定义
2、根据风险划分设施设备关键等级
2.1设备现场举例:SIA及CCA应用
2.2药厂所有设备的等级划分要点
2.3不同关键等级的设备,如何划分不同部门职责
2.4建立企业定期风险评估制度
3、通过风险建立设施设备预防性维护计划PM
3.1制定PM的年度计划及监督执行
3.2 一份完善的PM表格示例 3.3常见问题分析
4、设施设备维修工作开展
4.1如何建立设备技术文件支持维修工作
4.2cGMP维修工作的流程
4.3紧急事件同偏差变更流程的联系
4.4 维护和维修如何影响GMP状态/ 再验证
三)实战应用:设施设备不同系统版块的管理
1、备品备件库管理
1.1 如何从日常工作中量化备品备库日常工作量
1.2 备品备件库管理常用SOP举例
2 、仪表校准管理
2.1 通过风险评估建立校准及周期管理总目录
2.2 外送及自校的注意事项 
2.3认证时校准相关文件的准备
3、维护和维修的能耗费用管理
3.1 维护和维修,定义费用统计的必要性及方法
3.2 公司建立内部报废评估体系 
3.3报废流程

专家简介

惠老师:拥有超过20年制药行业工程建设和设备管理经验。先后于跨国制药及国内知名制药企业任职。目前负责集团新工厂筹建、工程维修维护体系制定及工程合规体系的把控。对国内外工程GMP合规、FDA审计及卓越化运行有丰富的经验
闫老师:曾在知名药企工程设备总监,对工程项目管理、设备维保管理、信息管理、安全管理都有丰富的实战经验。

会议说明

1.理论讲解,实例分析,专题讲授,互动答疑

2.主讲嘉宾均为行业内资深专家,欢迎来电咨询

3.企业需要内训和指导,请与会务组联系

参会费用

2800元/人(会务费包括:培训、会议中餐、答疑、讲义、培训证书、茶歇等);4月15日前报名并汇款,优惠至2500元/人。开具增值税发票,请把发票信息一并发送会务组。

汇款账号

汇款请注明:设备维保培训
户   名:北京凯晟共赢企业管理有限公司
开户行:中国工商银行股份有限公司房山支行良乡支行
账   号:020 031 690 910 006 9663
行   号:102100002644

报名回执

福田美术馆是由福田区政府投资兴建的大型公益性文化场馆,集展览、收藏、研究、交流及公共艺术教育于一体,担负“弘扬优秀传统文化、典藏大家艺术精品、加强国际国内交流、惠及公共文化服务”的职责,积极围绕深圳建设中国特色社会主义先行示范区的高标准、高要求,促进国际艺术交流,提升城市文化品位,为艺术家提供交流、借鉴和学习的平台,为公众提供美育教育和丰富的精神文化生活。

目前此课题正火热报名中,众多行业龙头即将参会,名额有限,有意向参加的企业可扫描下方二维码报名 !

扫码报名报名负责人

培训报名负责人:郑滨

微信/手机:18514026598

感兴趣的朋友请尽快落实一下人员

组团报名可享受优惠 欢迎咨询报名

↓↓↓ 医药行业1000人大会邀您莅临指导

       

       

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  1. CONNECT:[ UseTime:0.001161s ] mysql:host=127.0.0.1;port=3306;dbname=b460;charset=utf8mb4
  2. SHOW FULL COLUMNS FROM `fenlei` [ RunTime:0.001475s ]
  3. SELECT * FROM `fenlei` WHERE `fid` = 0 [ RunTime:0.000717s ]
  4. SELECT * FROM `fenlei` WHERE `fid` = 63 [ RunTime:0.000623s ]
  5. SHOW FULL COLUMNS FROM `set` [ RunTime:0.001334s ]
  6. SELECT * FROM `set` [ RunTime:0.000610s ]
  7. SHOW FULL COLUMNS FROM `article` [ RunTime:0.001486s ]
  8. SELECT * FROM `article` WHERE `id` = 511118 LIMIT 1 [ RunTime:0.002065s ]
  9. UPDATE `article` SET `lasttime` = 1774208318 WHERE `id` = 511118 [ RunTime:0.016165s ]
  10. SELECT * FROM `fenlei` WHERE `id` = 65 LIMIT 1 [ RunTime:0.000667s ]
  11. SELECT * FROM `article` WHERE `id` < 511118 ORDER BY `id` DESC LIMIT 1 [ RunTime:0.001185s ]
  12. SELECT * FROM `article` WHERE `id` > 511118 ORDER BY `id` ASC LIMIT 1 [ RunTime:0.000993s ]
  13. SELECT * FROM `article` WHERE `id` < 511118 ORDER BY `id` DESC LIMIT 10 [ RunTime:0.001894s ]
  14. SELECT * FROM `article` WHERE `id` < 511118 ORDER BY `id` DESC LIMIT 10,10 [ RunTime:0.007235s ]
  15. SELECT * FROM `article` WHERE `id` < 511118 ORDER BY `id` DESC LIMIT 20,10 [ RunTime:0.011674s ]
0.139803s