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尊敬的用户,您好!

       2018年7月美国药典“药物稳定性研究方案”、”非无菌与无菌药物的微生物质量控制与检测精要”培训课报名还剩8天,欲报从速!

  • 药物产品的稳定性研究方案
    Stability Program of Pharmaceutical Products
    2018年7月13日   南京
  • 美国药典非无菌与无菌药物的微生物质量控制与检测精要
    Essentials of Control and Testing of Microbial Quality of Nonsterile and Sterile Products
    2018年7月16-17日  上海
  • 溶出度方法的开发和验证
    Development and Validation of Dissolution Procedures
    2018年8月13-14日  上海
 

药物产品的稳定性研究方案

Stability Program of Pharmaceutical Products

课程时间/地点:
2018年7月13日     南京

课程简介:
       稳定性研究在药物产品开发过程中起着至关重要的作用。可持续的稳定性方案对新药注册和支持药品市场营销都非常关键。

      课程通过全面阐述FDA与ICH指南、行业惯例以及美国药典相关要求,在法规、执行操作、测试、调查等方面对小分子药物的稳定性方案进行深入介绍。课程将讨论广泛应用于稳定性方案设计的GMP、USP、FDA、ICH、WHO相关法规,为建立药品有效期和储存信息提供支持。同时,课程将对监控整个药品货架期质量的稳定性指示方法的开发和验证要求、简化试验方法(矩阵法和括号法)、稳定性数据评估和OOS调查等内容进行详细介绍。通过丰富的实例分析,您将学习如何设计兼具成本效益与合规性的全球稳定性方案。

参加对象:
        QC分析员/经理/总监、QA人员、法规事务员、审查员、分析技术员、稳定性研究协调员、CMC提交审核员等。参加者包括所有必须深入了解相关FDA法规和ICH指导原则以建立、实施和管理稳定性方案或测试的人员。

讲师:
        USP资深药典培训特聘专家

课程详情和报名方式:

       登录USP会议与课程中文系统 (www.usp-edu.org),或点击以下链接获取课程详情、进行在线报名(报名截止日:7月6日)。

                                                 

 

美国药典非无菌与无菌药物的微生物质量控制与检测精要

Essentials of Control and Testing of Microbial Quality of

Nonsterile and Sterile Products

课程时间/地点:
2018年7月16-17日     上海

课程简介:
       微生物检测是医药产品质量控制的重要部分,随着我国医药产品出口规模的扩大,尤其是进入法规市场的步伐加快,国内企业对相关国际质量要求的关注不断增加。

      本课程由美国药典委员会总部微生物专家亲临授课。作为美国药典多年来深受业界欢迎的经典培训课程之一,课程紧随药典更新的脚步,在介绍制药行业微生物规则要求的同时,全面阐述现行美国药典微生物检测相关通则、良好微生物实验室管理等内容要求。课程将帮助企业了解法规市场微生物检测领域的最新规定,帮助准确理解药典要求并评估可能对企业产生的影响。

       课程涵盖以下通则内容:<61>非无菌产品的细菌计数测试、<62>非无菌产品的微生物测试、<71> 无菌测试、<85>细菌内毒素试验、<1111>非无菌产品的药物制剂和药用原料的接受标准、<1112>非无菌药品中水分活性确定的应用、<1115>非无菌药物原料和药品的微生物控制、<1116>无菌工艺环境中的微生物控制和监测、<1117>良好微生物实验室管理、<1227>微生物回收率验证、<1229>药典物质灭菌、平皿计数的可变性等内容。

会议主办与承办:
       主办方:美国药典委员会中华区总部 USP-China
      承办方:北京中仑工业微生物研究院 CIMI

参加对象:
        制药、生物技术、辅料或相关行业的QA/QC/法规事务部实验室经理、主管、研究员、及其它专业人士。

讲师:
       Radhakrishna Tirumalai博士,美国药典委员会科学部门首要科学联络人

课程详情和报名方式:

       登录USP会议与课程中文系统 (www.usp-edu.org),或点击以下链接获取课程详情、进行在线报名(报名截止日:7月10日)。

                                                 

 

溶出度方法的开发和验证
Development and Validation of Dissolution Procedures

课程时间/地点:
2018年8月13-14日     上海

课程简介:
       生物利用度在国内外仿制药申报和审批流程中是不可缺少的评价项目。作为其重要指征,溶出度对药品的质量、效力和安全起着尤为重要的作用。溶出度测试被通用于大多数制剂(如片剂、胶囊、混悬剂、透皮贴剂、栓剂等)的体外性能测试。美国药典委员会推出的“溶出度方法的开发和验证”课程为相关部门进行批放行和稳定性测试提供溶出度方法开发和验证基础,并讲授与之相关的欧美现行规范及综合考量因素。

      课程为溶出度高级培训课程,由资深USP总部专家来华授课。根据2015年8月1日正式生效的USP 38–NF 33第一增补中通则<1092>的重大修订要求,本次课程内容做了全面修订。在介绍美国药典溶出度测试要求的基础上,课程将详细阐述基于API理化属性的溶出与药物释放测试的开发、生理学的考虑、溶出度测试条件的选择、如何设定接受标准、分析仪器验证、溶出度方法的验证等内容。通过深入解析与案例分析,课程将帮助您加深对溶出度方法开发和验证的理解,并将其快速应用于实际工作中。

参加对象:
        从事溶出度测试的科研人员、化学分析员和技术员;实验室经理;质量控制人员;产品开发和工艺研究人员(建议参加者在制药或相关行业有至少2年的工作经验)。

讲师:
        Erika S. Stippler 博士,美国药典委员会制剂性能实验室首席研究员

课程详情和报名方式:

       登录USP会议与课程中文系统 (www.usp-edu.org),或点击以下链接获取课程详情、进行在线报名(报名截止日:8月6日)。

                                                

 

2018年 USP-China药典培训、用户论坛及其它市场活动计划

 

       感谢您一如既往的支持,欢迎您继续关注我们的邮件通知及官方网站,了解USP即将举行的其他药典培训课程和市场活动。

美国药典中华区总部
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电话:+86 21 6861 9800
传真:+86 21 6861 9810
电邮:uspcn@usp.org
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官方微信:

 

 

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