Since Blue Bell Consulting launched its 揙pen Training� and 揙n-site Training� services in 2005, we have been receiving enormous interests from domestic pharmaceutical companies. Our courses are very popular among the staff in the pharmaceutical industry.
Blue Bell Consulting抯 primary service is to provide consulting services regarding the export of finished dosage forms. Since the start of our training, we have set up training courses on the registration and manufacturing of pharmaceutical products. Through significant amounts of interaction with our trainees, we made statistics on the questions our trainees raised during and after the training courses; hence, giving us the opportunity to understand and recognize, at a much deeper level, China抯 pharmaceutical company抯 pressing requirements and the problems they may have faced. In order to meet the requirements of these domestic companies, BBC has additionally added onto the fundamental and original course materials newer and more up-to-date topics, allowing the whole training program to be more systematically thorough.
2006 Course Listing:
cGMP: Interpretation & Application (Drug Product)
cGMP: Interpretation & Application (BPCs & APIs)
cGMP: Compliance Auditing
cGMP: Compliance Auditing (Sterile Pharmaceuticals)
cGMP: Laboratory Controls
cGMP: Batch Records Review and Investigations
cGMP: Qualification and Validation
FDA: Computer System Validation and ER/ES
FDA Regulations: New Drugs & Generic Drugs
cGCP: Interpretation & Application
The training materials of our training courses are elaborately developed by experts in all related fields and annually updated in accordance with latest regulations and guidances issued by the U.S. FDA as well as its interpretations. A good number of these experts have compiled works the training materials used by the U.S. and well-known international pharmaceutical companies. These training materials encompass not only their great intellectual theories, but rich practical experiences as well. The training materials are all very systematic, detailed, authoritative, and practical, allowing all the trainees to get the latest and most authoritative U.S. FDA regulations and guidance interpretations.
The basic motto of Blue Bell Consulting抯 training program is 搇earning for the purpose of application.� Pure Chinese materials might cause misunderstandings due to the possible inappropriate translations, thus we adopted an original English version of the training materials attached with a Chinese translation that will assist in better understanding of the content, making it more distinct, thorough, and genuine for the trainees as they try to grasp all the concepts pertaining to the materials. There is also an additional improvement being emphasized on English professional vocabulary terms pertaining to this field, thereby, rapidly heightening and improving the trainees� professional experiences based on the knowledge gained from our training program.
The purpose of Blue Bell Consulting抯 training courses is to let the trainees 搖nderstand the whys and the where-fores.� The content of our course materials have a list of detailed reference information allowing our trainees to know where the material comes from, such as GMP regulations, the preamble, guidances, inspection guides, compliance procedures, cGMP Notes, 483, warning letters, podium policies, meeting minutes, or court rules etc. If the course materials or explanations contain personal points of views from the instructors, the instructor will explain accordingly. The objective of Blue Bell Consulting抯 training courses is for the trainees to earnestly grasp the concepts of GMP and its most fundamental requirements, so that the most accurate reference and advisory opinions could be offered when the company is implementing GMP; to master the most practical GMP requirements during the business negotiation with international clients; to respond the inspectors in the most accurate form of expression during the possible on-site inspection.
Since the launch of our training courses, there have been many faithful previous trainees who not only successfully completed our entire training courses, but also urged their company抯 management staff and individual employees to participate in our training courses. Blue Bell Consulting抯 open training courses resulted in the development of our 揙n-site Training;� consequently, some of China抯 pharmaceutical companies have repeatedly invited BBC to carry out on-site training for their different departments, insisting on providing each and every one of their employees an opportunity to participate in BBC抯 training course, expecting an even more effective administration in the internationalization process of its management and manufacturing controls.
At the end of the year in 2005, BBC co-hosted a training course entitled 揢S FDA cGMP Compliance for Pharmaceutical Companies� with the training center of SFDA, the trainees provided fairly good feedbacks along with a strong request for attending more courses. Thanks to the quality feedback from the trainees, BBC, associated with the training center of SFDA, hosted the course again in March 2006 to meet the needs of such kind of trainings. Considering that the computer system validation just started in the domestic pharmaceutical companies, BBC, collaborated with SFDA training center, hosted a training course entitled 揷GMP: Computer System Validation and ER/ES,� in April of 2004, inviting senior expert from Yamatake, a famous Japanese company in this field, to co-instruct.
Through training, the trainees� understanding of how BBC抯 consulting services work has strengthened. We hope to strengthen the ties between BBC and pharmaceutical companies which may lead to more collaborations and mutual benefits.
Attendees by Company Names:
Abbott S.A.
Affiliated Hospital of Nanjing University of TCM
Allergan (Hangzhou) Pharmaceutical Co., Ltd.
Apeloa (Kangyu) Pharm Co., Ltd.
Arch Chemicals (Suzhou) Co., Ltd.
AstraZeneca (China)
Bayer Healthcare Co., Ltd.
Bayer Technology Services
Beaufour Ipsen Tianjin Pharmaceutical Co., Ltd
Beijing Four-ring Pharmaceutical Co., Ltd.
Beijing Fresenius Dabi Pharmaceutical Co., Ltd.
Beijing Hanmi Pharmaceutical Co., Ltd.
Beijing Holley-Cotec Pharmaceuticals Co., Ltd
Beijing Joinn Pharmaceutical Center
Beijing NOVARTIS PHARMA Ltd.
Beijing Pharmaceutical Group Co., Ltd.
Beijing Second Pharmaceutical Co., Ltd.
Beijing Wanshun Technology Co., Ltd
Beijing Zizhu Pharmaceutical Co., Ltd
Bristol-Myers Squibb Company (China)
Changzhou Siyao Pharmaceuticals Co., Ltd.
China Otsuka Pharmceutical Co., Ltd.
China Pharmaceutical University Pharmaceutical Co., Ltd.
Colorcon Inc.
Covance Inc.
Daiichi Pharmaceutical (Beijing) Co., Ltd.
Degussa China Nanning Only-Time Rexim Pharmaceutical Co., Ltd.
Ferring Pharmaceutical (China) Co., Ltd.
Forward Group
GlaxoSmithKline (China) Investment Co., Ltd.
GlaxoSmithKline Pharmaceuticals (Suzhou) Ltd.
Hainan Hailing Pharm Co., Ltd.
Haitai Information Technology Co., Ltd.
HAND Enterprise Solutions Company Ltd.
Hansenpharm (China) Co., Ltd.
Hebei Changshan Biochemical Pharmaceutical Co., Ltd.
Hebei Shengxue Dacheng Pharmaceutical Co., Ltd.
Hebei Veyong Bio-chemical Co., Ltd.
Holly Pharmaceuticals (Chongqing) Co., Ltd
Huayu (Wuxi) Pharmaceutical Co., Ltd.
Inverness Medical Shanghai Rep. Office
Jiangsu Yangtze River Pharmaceutical Group Shanghai Haini Pharmaceutical Co., Ltd
Kunshan Rotam Reddy Pharmaceuticals Limited
Lukang Pharmaceutical Import and Export Corporation
Meiji Lukang Pharm, Ltd.
Minsheng Pharmaceutical Group Co.,Ltd.
Mundipharma/NAPP /P.F.
NCPC Aino Co., Ltd.
NCPC Huari Pharmaceuticals Co., Ltd.
NCPC Create Pharm. Co., Ltd.
NCPC Haixiang Pharm. Co., Ltd.
NCPC Orchid Pharm. Co., Ltd.
Novo Nordisk (Tianjin) Biotechnology Co., Ltd.
Pfizer Pharmaceutical Limited Suzhou Plant
Rhodia (Wuxi) Pharmaceutical Co., Ltd.
Sanjiu Medical & Pharmaceutical Co., Ltd.
Schering (Guangzhou) Pharmaceutical Ltd.
Servier (Tianjin) Co., Ltd.
Shaihai Meilian Biotechnologies Incorporation
Shandong Lukang Pharmaceutical Group Co., Ltd.
Shandong Luye Pharmaceutical Co., Ltd.
Shandong Simcere Biotech Pharmaceutical Co., Ltd.
Shanghai Biological Pharm
Shanghai FOSUN Pharmaceutical (Group) Corporation Limited
Shanghai Haixin Pharm
Shanghai Huzhong Pharm
Shanghai Jonya Marine Biological Engineering Co., Ltd.
Shanghai Newsummit Biopharma Co., Ltd.
Shanghai Sankyo Co., Ltd.
Shijiazhuang Pharma. Weisheng Pharmaceutical (Shijiazhuang) Co., Ltd.
Shijiazhuang Pharmaceutical Co., Ltd.
Shijiazhuang Pharmaceutical Group Hebei Yuanzheng Pharmaceutical Co., Ltd.
Shijiazhuang Pharmaceutical Group Hebei Zhongjian Pharma Co., Ltd.
Shijiazhuang Pharmaceutical Group Ouyi Pharma Co., Ltd.
Shijiazhuang Shengcheng Pharmaceutical Co., Ltd.
Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd.
Simcere Pharmaceutical Group
Sino-swed Pharmaceutical Co., Ltd.
Southwest Synthetic Pharmaceutical Corp. Ltd.
Taizhou Candorly Sea Biochemical & Health Products Co., Ltd.
The General Pharmaceutical Factory of Harbin Pharmaceutical Group
Tianjin Tasly Pharmaceutical Co., Ltd.
Wrigley Confectionery (China) Limited
Wrigley Confectionery (Shanghai) Limited
WuXi PharmaTech He Quan Inc.
WuXi PharmaTech Inc.
Xiamen Traditional Chinese Medicine Co., Ltd.
Xian-Janssen Pharmaceutical, Ltd.
Xiaomen Amoytop Biotech Pharmaceutical Co., Ltd.
Yantai Medgenn Co., Ltd.
Zensun (Shanghai) Sci & Tech Co., Ltd.
Zhejiang Better Pharmaceutical Co., Ltd.
Zhejiang CONBA Pharmaceutical Co., Ltd.
Zhejiang Hisoar Pharm Co., Ltd.
Zhejiang Medicine Co., Ltd. Xinchang Pharmaceutical Factory
Zhejiang Wanma Pharamaceutical Co., Ltd.
Zhejiang Xianju Pharmaceutical Co.,Ltd.
Zhejiang Xianju Xianming Pharmaceutical Co., Ltd.
Zhongxin Pharmaceuticals
Zhumadian Chia Tai Co., Ltd.
(Last update in 12-12-2006)