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1、 KFCS 中华人民共和国，上海市浦东新区 中华人民共和国，上海市浦东新区 新金桥路 18 号民航大厦 2207-08 室 新金桥路 18 号民航大厦 2207-08 室 邮编:201206 邮编:201206 电话:86-21-3872 6803 传真:86-21-3872 6806电话:86-21-3872 6803 传真:86-21-3872 6806 Unit 2207- 08, Civil Aviation Center, 18 Xin Jin Qiao Road, Pu Dong District Shanghai, P.R.China 201206 Tel: 86- 21- 38
2、72 6803 Fax:86- 21- 3872 6806 1 of 3 2010- 1- 10 特色产品：对特色产品：对 cGMP 培训师的培训培训师的培训 Featured Service: cGMP Trainers Training 您经历的某些 GMP 培训，是否有如下感受？ Do you have following feelings after some GMP training? “我一年前是接受过相关培训，不过一直用不上，现在已经快忘光了。” “I received a related training one year ago. But I never use the kn
3、owledge. Now I almost forget what the training session is about.“ “这个培训和我的工作关系不大，我还是有很多问题没得到解决。” “It has little relationship to my work. Many of my questions are not resolved.“ “这个培训师一个劲地自己说话，我几乎都睡着了。” “That trainer seems to talk to himself. I almost fall asleep.“ “太复杂了，听得我都晕了，根本记不下来。” “Too complex.
4、 I cannot remember all.“ 根据我们的经验，如果 GMP 培训收效不大，那么主要原因通常是下面几类： According to our experience, following are the major causes of failure of GMP training: 培训后，培训对象没有实习的机会； Trainees have no oppotunity to exercise after training; 培训内容太过泛泛，并非针对培训对象的工作需要； Training is too general to be specific on trainees wo
5、rking functions; 培训方式简单生硬，培训对象接受度不高； Training is conducted in an inattractive way; 培训中只告诉培训对象如何去做，而没有解释为什么要这样去做。 Only “what to do“, but not “why to do“. 服务定义服务定义 Definition of Service 为此，我们对 cGMP 培训服务进行了专门的设计。我们服务的定义是： To address above failure causes, we design our GMP training service as following:
6、 u 培训对象：企业中层的 15 25 人，因为他们通常决定了企业质量管理的有2 of 3 2010- 1- 10 效性，通常他们也是企业内部的培训师。他们接受培训后，需要在企业内 部对其他人员进行培训。科学研究表明，看书对知识的掌握程度为 10%， 听 20%，边看边听 30%，讨论 50%，亲身经历 80%；而主动去教别人的 话，掌握程度达到 90%。 Trainees: 15 25 persons at operation manager level. Generally they have critical impact on effectiveness of quality mana
7、gement, and generally they are the trainers of the company. After receiving trainers training, they will give their own training in company. Scientific data show that 10% knowledge can be learnt by watch, 20% by listen, 30% by watch on the other hand, it is easy to get management support at this tim
8、e. u 培训地点：在企业本部或企业安排的地点。 Training Site: in- house, or any site selected by customer company. u 培训内容：根据企业需要而定。我们建议在初次培训之前的某个时间，我 们的培训师对企业需要培训的方面做一个一天左右的审计。一方面有利于 我们设计针对性的培训，另一方面也有利于企业了解培训师的能力。 Training Content: tailored for company needs. We suggest our trainer doing a one- day audit to your company
9、at the aspect that training will focus on. Thus our trainer can design training specific for your needs, and you have oppotunity to know the ability of our trainer. u 培训方式：授课、课堂活动和专题讨论。根据培训需要而定。 Training Method: presentation, activity or topic discussion. Tailored for training needs. u 培训资料：我们所有的培训资
10、料都是培训师自己设计的，并且根据不同企 业的实际情况而修订。 Training Materials: all training materials are prepared by our trainer himself. Our trainer may revise training materials according to customers actual situation. u 培训组织：我们的培训师同时也是有丰富经验的项目管理人员。在培训之 前，我们和企业设定一个共同的目标。根据目标设定、时间限制和预算， 我们组织培训活动，包括培训对象回到企业后需要进行的后续培训。 Organiz
11、ation of Training: our trainers are also experienced in project management. We will manage training activities according to objective, time limit and budget. We will also follow- up the trainees exercise after coming back to customer company. 3 of 3 2010- 1- 10 课程举例课程举例 Course Example u GMP 的法律渊源和基本
12、原则 GMP Essential u 质量科学的历史和基本方法 History and Method of Quality Science u 法规和指南 Regulations and Guidance u 文件管理 Documentation u 变更控制 Change Control u 验证 Validation u 供应商管理 Supplier Management u GMP 环境中的项目管理 Project Management in GMP Environment u 风险评估 空调系统和水系统 Risk Assessment HVAC and Water System u F
13、DA 检查准备 FDA Inspection Preparation u 培训课程设计和培训师技巧 Training Course Design and Trainers Skills u 其它根据项目需求而安排的培训 Other training courses designed for project requirements 如您对我们的如您对我们的 cGMP 培训师培训感兴趣，请通过下面方式联系我们：培训师培训感兴趣，请通过下面方式联系我们： If you have interest in our cGMP trainers training, please contact us: E- mail: CELL: 136 5161 5863 TEL：021 3872 6803 FAX：021 3872 6806 CONTACT: 刘禹（Alex Liu）
