弗戈制药工程国际论坛 2012论坛日程

文章来源:弗戈工业在线 发布时间:2012-04-12
6月27日 听众注册报到
09:00~17:00 听众注册报到  
  Audiences registered  
6月28日上午 开场致辞 演讲人
08:50~09:00 主办方致辞 肖捷,PROCESS出版人
  The host unit delivers speech Lucy Xiao, PROCESS China Publisher
09:00~09:10 大会主席致辞 任德权,国家食品药品监督管理局原副局长
  Forum Chairman delivers speech Ren Dequan, SFDA
09:10~09:20 制药工程国际论坛的宗旨和目标 孙小兵,PROCESS《流程工业》高级顾问
  The purpose to  hold Vogel International Pharmaceutical Engineering Forum Sun Xiaobing, Senior Consultant of PROCESS China
无菌制剂分论坛 Aseptic preparations(6月28~29日)
6月28日 演讲题目  
9:30~10:20 2010版药品GMP认证常见问题及分析 张华,上海市食品药品监督管理局认证审评中心首席认证员兼GMP部部长
  Common problems and analysis of 2010 GMP certification Zhang Hua,Shanghai Food and Drug Administration
10:20~11:00 新法规下无菌药品质量管理 沈菊平,江苏正大天晴药业股份有限公司质量总监
  The quality management of sterile products in event of new regulations Shen Juping, Quality Director, Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd
11:00~11:20 茶歇
11:20~12:00 冻干工艺的质量管理和风险控制 郑金旺,上海东富龙科技股份有限公司技术总监
  Quality management and risk control over freeze-drying process Zheng Jinwang, Technical Director, Shanghai Tofflon Science and Technology Co.,Ltd
12:00~14:00 午餐
14:00~14:40 洁净公用工程系统的质量风险与解决方案 张功臣,奥星公司水系统业务单元技术经理
  Quality management and risk control over the clean public engineering system Philip Zhang, Technical Manager of Liquid Process System Engineering,  Austar Group
14:40~15:20 新版GMP对除菌滤芯的验证要求之——细菌挑战实验与溶出物/析出物评估 武富,杭州科百特过滤器材有限公司验证中心
  The new GMP requirement of aseptic filtration—bacteria challenge experiment and dissolution /deposition test evaluation Wu Fu, Hangzhou Cobetter Filtration Equipment Co., Ltd
15:20~15:40 茶歇
15:40~16:20 讨论
6月29日 演讲题目  
9:00~9:40 无菌原料药的工艺模拟 邓海根,中国医药设备工程协会高级顾问
  Process Simulation of sterile APIs Deng Haigen, Senior Consultant,China  Pharmaceutical Association of Plant Engineering
9:40~10:20 ICHQ9原则在无菌工艺生产中的实际应用 陈柏林,中国制药装备行业协会顾问
  Application of ICHQ9 principle in aseptic processes Chen Bolin, Domestic GMP expert
10:20~10:40 茶歇
10:40~11:20 无菌生产中洁净室的环境监测 国内知名微生物污染控制专家
  Cleanroom environment monitoring in aseptic production Domestic famous microbial pollution control expert
11:20~12:00 制药用水系统的设计要点 王伟,上海净泽洁净设备有限公司营运经理
  The main points of designing pharmaceutical water system William Wang, General Manager , Winatech Process Engineering( Shanghai)Co.,Ltd
12:00~14:00 午餐
14:00~14:40 无菌生产工艺和设备选择 Anwarul Haque,奥星验证咨询服务部验证总监
  Steril manufacturing process and equipment selection Anwarul Haque,Validation Director,Austar Validation Consultancy Service Department
14:40~15:20 欧洲制药业先进的物流及配送系统 Harald J. Geitz, 德国吉欧项目管理咨询有限公司董事总经理
  Advanced logistics and distribution system in European pharmaceutical industry Harald J. Geitz, Managing Director, i+o Industrieplanung + Organisation GmbH & Co. KG
15:20~16:20 讨论
  Discussion
固体制剂及原料药分论坛Solid preparations and API(6月28~29日)
6月28日 演讲题目 演讲人
9:30~10:10 从工业界视角看中国CMC法规环境现状 桂敏, 博士, 百时美施贵宝公司, 全球法规科学部, 亚太CMC, 中国CMC, 运营及法规策略管理总监; RDPAC药学专业组主席; ISPE药政委员会资深成员
  Current status of CMC regulatory environment in China from industry perspectives Min Gui, PhD, Director, CMC Asia Pacific, China CMC, Operation & Regulatory Strategy Management, Global Regulatory Sciences, Bristol-Myers Squibb; Chair of RDPAC CMC Focus Group; Member of ISPE Regulatory Affair Committee
10:10~10:50 如何为药品构建一个稳健的质量体系 ISPE基准指南《口服固体制剂》译者
  How to build a robust quality  system for pharmaceutical product? The translator of Oral Solid Preparation, ISPE Baseline Guide
10:50~11:10 茶歇
11:10~12:00 固体制剂产品设计和设施设计中的质量风险管理 雷继峰,上海安必生制药技术有限公司CEO
  Quality risk management in OSD product design & facility design Lei Jifeng, Founder and CEO of Shanghai Anbison Lab. Co. Ltd
12:00~14:00 午餐
14:00~14:40 溶出度技术提高固体制剂的内在品质 谢沐风,上海市食品药品检验所
  The dissoluting technology improves the intrinsic quality of the solid preparation Xie Mufeng, SIFDC
14:40~15:20 实例分享-新建厂房项目验证的组织及实施 赵云霞,发泰(天津)科技有限公司质量部经理
  Case study-organization and implementation of new building project verification Zhao Yunxia, Validation Manager, Pharm-Tech
15:20~15:40 茶歇
15:40~16:20 中药提取工艺中的节能设计 钱潍生,山东省医药工业设计院前院长
  Energy saving design of the traditional Chinese medicine extraction technology Qian Weisheng, Former Director, Shandong Province Design Institute of Pharmaceutical Industry
16:20~17:00 传统中药质量控制方法在国际化道路上的探索 叶正良,天津天士力之骄药业有限公司董事长兼总经理,天士力集团FDA-CMC项目总监
  Exploration of traditional Chinese medicine quality control methods in the internationalization way Ye Zhengliang, Chairman & General Manager of Tianjin Tasly Pride Pharmaceutical Co., Ltd.,  Project Director of the FDA-CMC Project of Tianjin Tasly Group Co., Ltd
17:00~18:00 讨论
  Discussion
6月29日 演讲题目 演讲人
9:00~9:40 新版GMP对工艺设计、验证的新要求 王彦忠,中美史克制药有限公司质量部验证经理
  The new requirements to the process design and validation by the new version of Chinese GMP Wang Yanzhong, Quality Validation Manager, Tianjin Smith Kline & French Laboratorles Ltd
9:40~10:20 自动化与精益生产在欧美及印度的发展 赵明,英国迈康有限公司中国区总经理
  The trend of automation and lean manufacture in India and Europe Zhao Ming, China General Manager, British Matcon Co.,Ltd
10:20~10:40 茶歇
10:40~11:20 在封闭的系统中进行制剂的生产 AZO安卓物料自动化系统(天津)有限公司
  Preparation production  In closed system AZO Ingredients Automation System (Tianjin) Co., Ltd
11:20~12:00 制药工业的清洁消毒 白佳,艺康集团全球副总裁/艺康大中华区食品饮料事业部总经理
  Clean and disinfection in pharmaceutical industry
 
James Bai, Vice President & Managing Director of F&B + Water, Energy, Waste solution,Ecolab Inc
12:00~14:00 午餐
14:00~14:40 高效的固体制剂包装方案——多道枕式包装的应用 王曦梅,发泰(天津)科技有限公司技术副总经理
  Efficient solid preparation packaging solution—application of multi-channel pillow packaging Wang Ximei,  Vice Technical Manager, Pharm-Tech
14:40~15:20 TOC应用于制药设备的清洁验证 谷雪蔷,GE发电设备与水处理集团分析仪器市场及应用经理
  Application of total organic carbon (TOC) in the equipment cleaning validation Paulina Gu, Marketing and Application Manager of Analytical Instruments, GE General Electric (China) Co., ltd
15:20~16:20 讨论
信息化和自动化分论坛 Informatization and Automation(6月28~29日上午)
6月28日 演讲题目 演讲人
9:30~10:10 药品电子监管 王迎利,国家食品药品监督管理局副处长
  Drug electronic supervision Wang Yingli, Deputy Director ,State Food and Drug Administration
10:10~10:50 从一体化工程设计到一体化运营 赵准,西门子工业软件(上海)有限公司 COMOS 产品经理
  From Integrated Engineering to Integrated Operation Zhao Zhun, Product Manager COMOS, Siemens Industry Software (Shanghai) Co., Ltd.
10:50~11:10 茶歇
11:10~12:00 自动化与信息化——确保药品质量的必经之路 汤继亮,上海医药工业研究院研究员
  Informatization and Automation—The necessary way for ensuring the quality of medicines Tang Jiliang, Researcher, Shanghai  Institute of Pharmaceutical Industry
12:00~14:00 午餐
14:00~14:40 Fade or flourish?Rethinking the role of life sciences companies in the healthcare ecosystem 李南平,IBM大中华区医疗与生命科学商业拓展总监
  Fade or flourish?Rethinking the role of life sciences companies in the healthcare ecosystem Lisa Li ,Healthcare (and Life Sciences) Strategy and Business Development Executive,IBM GCG Public Sector
14:40~15:20 DCS系统在新型头孢无菌原料药项目中的应用 王晓松,ABB中国过程自动化业务部控制技术本地业务单元工程经理
  Application of DCS system in the new cephalosporin aseptic API project Wang Xiaosong ,Engineering Manager,Control Technologies,Process Automation division,ABB China Ltd
15:20~15:40 茶歇
16:00~16:40 仓储区域的温度分布研究和验证 Bruce McDuffee, 维萨拉生命科学事业部全球市场部经理
  Validation temperature mapping for storage areas Bruce McDuffee,  Global Marketing Manager, Life Science Division, Vaisala
16:40~17:20 人机界面HMI 在制药工业中的应用 管磊,倍加福(北京)过程自动化控制设备有限公司
  HMI Solutions for pharmaceutical production Guan Lei,  Pepperl+Fuchs (Beijing) Process Automation Control Equipment Co., Ltd
17:20~18:00 讨论
生物制剂分论坛 Biopharmaceutical(6月29日)
6月29日 演讲题目 演讲人
9:00~9:40 在中国设计及建设现代化单克隆抗体项目的经验分享 David Liu,生物技术经理,PM Group
  Sharing experience in designing & building up modern mAb facility in China David Liu, Biotechnology Manager, PM Group
9:40~10:20 GEP规范在制药工程项目中的运用探讨 冯力,上海生物制品研究所有限责任公司工程部副经理
  Application of GEP in pharmaceutical engineering projects Feng Li, Deputy Manage of Engineering Department, Shanghai Institute of Biological Products Co., Ltd
10:20~10:40 茶歇
10:40~11:20 生物制剂厂房建设经验分享 陈凯东,日挥株式会社,事业推进项目本部,都市基础设施开发部,生命科学组担当课长
  Sharing experience in biopharmaceutical factory's design & building up Chen Kaidong, Section Supervisor of Life Science Team, Urban Infrastructure Development Department, Business Promotion Project Department, JGC Corporation
11:20~12:00 过氧化氢灭菌系统在无菌生产系统中应用 刘前进,奥星集团设备与工艺系统事业部销售经理
  The application of hydrogen peroxide sterilization system in sterile production system Liu Qianjin, Region Sales Manager, Equipment & Process Systems Business Divisions, Austar Group
12:00~14:00 午餐  
14:00~14:40 无菌制剂生产中的隔离技术 吴文蕾,上海东富龙爱瑞思科技有限公司技术部经理
  Barrier isolation technology in the pharmaceutical aseptic processing Wu Wenlei, Technical Manager, Shanghai Tofflon AIREX Science and Technology Co.,Ltd
14:40~15:20 疫苗工艺验证与质量提高 王辉,总经理助理兼质保部经理,北京天坛生物制品股份有限公司
 
  Vaccine process validation and quality improvement Wanghui, General ManagerAssistant & Quality Assurance Manager,
Beijing Tiantan Biological Products Co.,Ltd
 
15:20~16:20 讨论
  Discussion
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