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南昌 | 2025版《中国药品检验标准操作规范》检测方法新规要求重点全解析及如何转化应用专题研讨班

  • 2026-07-16 18:39:25
南昌 | 2025版《中国药品检验标准操作规范》检测方法新规要求重点全解析及如何转化应用专题研讨班

培训

通知

南昌·法规专题

07月18-19日

培训指南

为帮助广大医药检验从业人员精准掌握新版规范修订要点,吃透各类检测项目的新标准、新流程,破解日常检验中的操作不规范、数据处理出错、设备管控不到位等实操难题,规避合规缺陷风险,特开设本次专题研修班。

课程围绕2025版《中国药品检验标准操作规范》全部重点检测方法展开全面解析,覆盖数据运算、常用仪器、色谱光谱、薄层色谱法、理化检测等全品类项目,结合规范条文解读、实操要点梳理与易错问题分析,全方位夯实检验人员专业功底。助力参训人员严格对标新版规范开展日常工作,实现检验操作标准化、数据管理合规化,持续筑牢药品质量安全防线。

培训时间

07月18-19日(17日报到)

培训地点

江西·南昌

培训主题

2025版《中国药品检验标准操作规范》检测方法新规要求重点全解析及如何转化应用专题研讨班

培训讲师

中食药集团专家顾问团特约讲师,正高级药品系列工程师,药品审评外聘专家,GMP检查员。参与《中国药典》通用技术要求研究工作。工作期间承接多个质量标准起草、方法学验证、申报资料撰写、药审中心发补的回复咨询及技术支持等多项工作,多个品种已成功通过药审中心评审获得生产批件。作为组长多次参加化药、中药、生物药的GMP符合性检查、注册核查等多项核查工作。同时作为多家企业技术顾问,对质量保证与质量控制有深刻理解。

培训详情
02
07月18日

主题一:2025版《中国药品检验标准操作规范》修订:有效数字修约运算新标准

1、药品检验有效数字判定规则

2、检验数值标准修约操作规范

3、检验数据四则运算精度要求

4、药典数值修约合规易错要点

主题二:2025版《中国药品检验标准操作规范》优化:高效液相色谱实操新规范

1、液相色谱仪器与耗材核查要求

2、流动相配制与系统平衡规范

3、系统适用性试验判定标准

4、样品检测与结果判定合规要求

主题三:2025版《中国药品检验标准操作规范》更新:气相色谱标准化操作新规

1、气相色谱设备与气源核查规范

2、升温程序与进样系统设置要求

3、气相系统适用性试验操作要点

4、检测异常排查与数据管控要求

主题四:互动—问题交流答疑

02
07月19日

主题五:2025版《中国药品检验标准操作规范》升级:电子天平精准称量操作准则

1、电子天平选型与检定校准要求

2、天平称量前环境与设备核查

3、药品样品标准称量操作流程

4、称量误差防控与数据记录要求

主题六:2025版《中国药品检验标准操作规范》新规:色谱数据系统合规管控指南

1、色谱系统软硬件合规配置要求

2、色谱数据采集与参数设定规范

3、色谱峰积分与数据处理规则

4、色谱数据完整性与追溯管理

主题七:2025版《中国药品检验标准操作规范》修订:薄层色谱法新标准

1、薄层色谱法仪器耗材合规判定规则

2、薄层色谱全流程标准化操作规范

3、薄层色谱试验数据计算与结果判定标准

4、薄层色谱检验合规易错要点与偏差管控

主题八:2025版《中国药品检验标准操作规范》提升:红外光谱合规检验操作指南

1、红外仪器校准与环境管控要求

2、样品制片与预处理标准规范

3、红外光谱采集与参数设置

4、图谱解析与结果判定合规要求

主题九:互动—问题交流答疑

04
培训费用

1、培训费:2500元/人

2、中食药®会员单位免费(食宿自理)

费用包含:会议期间证书费、场地费等。可提前汇款缴纳,建议提前汇款缴纳,如已提前汇款,报到时请出示汇款凭证。

住宿费用:培训期间住宿费,可由会务组统一安排,费用自理。

培训结束由中食药集团颁发培训证书,此证书为《培训合格证书》,可作为医药专业技术人员聘用、晋升、职称评定、继续教育或申报评定资格重要依据和职业能力考核的重要证明。

04
报名方式

会议负责人

◆ 负责人:孙艳丽(13810361796

◆ 负责人:王臻(13716596509)

自主报名:扫描下方二维码报名

05
会议支持

主办单位

中食药智慧教育管理平台

中食药(天津)医药科技集团有限公司

产业联盟支持

广东环凯微生物科技有限公司

南昌时空越科科技有限公司

微仪光电(天津)有限公司

厦门鹭珈聚芯生物科技有限公司

北京先驱威锋技术开发公司

深圳华大智造销售有限公司

天津市能谱科技有限公司

安徽普时锐仪器科技有限公司

李思特消毒科技(上海)有限公司

中食药致诚(山东)医药咨询有限公司

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  1. CONNECT:[ UseTime:0.000691s ] mysql:host=127.0.0.1;port=3306;dbname=aa460;charset=utf8mb4
  2. SHOW FULL COLUMNS FROM `fenlei` [ RunTime:0.000864s ]
  3. SELECT * FROM `fenlei` WHERE `fid` = 0 [ RunTime:0.000320s ]
  4. SELECT * FROM `fenlei` WHERE `fid` = 63 [ RunTime:0.000304s ]
  5. SHOW FULL COLUMNS FROM `set` [ RunTime:0.000484s ]
  6. SELECT * FROM `set` [ RunTime:0.000226s ]
  7. SHOW FULL COLUMNS FROM `article` [ RunTime:0.000582s ]
  8. SELECT * FROM `article` WHERE `id` = 539450 LIMIT 1 [ RunTime:0.003739s ]
  9. UPDATE `article` SET `lasttime` = 1784262763 WHERE `id` = 539450 [ RunTime:0.019589s ]
  10. SELECT * FROM `fenlei` WHERE `id` = 64 LIMIT 1 [ RunTime:0.000459s ]
  11. SELECT * FROM `article` WHERE `id` < 539450 ORDER BY `id` DESC LIMIT 1 [ RunTime:0.000544s ]
  12. SELECT * FROM `article` WHERE `id` > 539450 ORDER BY `id` ASC LIMIT 1 [ RunTime:0.001091s ]
  13. SELECT * FROM `article` WHERE `id` < 539450 ORDER BY `id` DESC LIMIT 10 [ RunTime:0.001827s ]
  14. SELECT * FROM `article` WHERE `id` < 539450 ORDER BY `id` DESC LIMIT 10,10 [ RunTime:0.001279s ]
  15. SELECT * FROM `article` WHERE `id` < 539450 ORDER BY `id` DESC LIMIT 20,10 [ RunTime:0.011311s ]
0.114745s