Serving the need to export drug products of pharmaceutical companies in China, in 2005 Blue Bell Consulting launched 揟raining Courses on U.S. FDA Regulations,� a series of authoritative, systematic, and practical courses focused on US FDA regulatory and compliance issues.
Among these courses, the GMP training course series use the same training materials as those used in the famous PharmaNet GMP training courses instructed by John Lee and others in U.S., France, Sweden, Italy, and Japan. The content was updated annually in accordance with US FDA new policies, guidances, 483s, warning letters, etc.
Chinese translations are available for most of our training materials, and to aid in a better understanding of the original English edition, English-Chinese versions of course materials are also provided for trainees. Through our detailed Chinese instructional explanations, our trainees are better equipped to comprehensively understand and truly grasp the concept of the knowledge that can be utilized in a direct parallel application to their daily work.
Domestic as well as international pharmaceutical establishments in China have found BBC a vital and popular resource in training mechanisms. After participating in our open training courses, many companies have found it benefiting to invite BBC experts to conduct on-site trainings at their respective establishments. In addition, Blue Bell Consulting also collaborated with the Training Center of State Food and Drug Administration and conducted training courses on similar topics. Our agenda also includes frequent invitations to attend GMP symposiums and seminars organized by provincial and municipal FDA branches in China.
In order to fulfill significant unmet needs of the medical device industry in China, BBC recently expanded our training topics to cover GMP/QSR for medical devices. With careful preparation of half a year, a new course on 揗edical Device cGMP/QSR: Interpretation & Application� has been officially launched during the second half of this year to help medical device manufacturers improve their quality system. The officially developed U.S. FDA course materials were used as internal training material for its own reviewers and inspectors.
2007 Course Listing:
cGMP: Interpretation & Application (Drug Product)
cGMP: Interpretation & Application (BPCs & APIs)
cGMP/QSR: Interpretation & Application (Medical Devices)
cGMP: Laboratory Controls
cGMP: Batch Records Review and Investigations
cGMP: Qualification and Validation
cGMP: Compliance Auditing
cGMP: Compliance Auditing (Sterile Pharmaceuticals)
cGCP: Interpretation & Application
FDA Regulations: New Drugs & Generic Drugs
FDA: Computer System Validation and ER/ES
Attendees by Company Names:
AMO (Hangzhou) Co., Ltd.
Amsino Healthcare (shanghai) Co., Ltd.
AstraZeneca (China)
Avilive Co.
Bayer Healthcare Co., Ltd.
BB Electronics Suzhou Co., Ltd.
Beaufour Ipsen Tianjin Pharmaceutical Co., Ltd.
Beijing Food and Drug Administration
Beijing GYLONGLI Sci. & Tech. Co., Ltd.
Boston Scienfific Corporation
Cemma Enterprise Co., Ltd.
Chongqing Huapont Pharm Co., Ltd.
Chongqing Yaoyou Pharmaceutical Co., Ltd.
Dongying Tiandong Biochemical Industry Co., Ltd.
Double-Dove Group
EPS China Co., Ltd.
General Electric Medical Systems (Shanghai) Company
GSD Inc.
Guangzhou Qixing Pharmaceutical Co., Ltd.
Hainan Hailing Pharm Co., Ltd.
Helongjiang Success Pharmaeutical Co., Ltd.
Horiba Trading (Shanghai) Co., Ltd.
Huai An Sigma Medical Industry Co., Ltd.
Jabil Circuit, Inc.
Jiangxi Sanxin Medical Devices Group Ltd.
Jiangsu Simcere Pharmaceutical Research Co., Ltd.
Kelun Industry Group
Lumenis China
Mead Johnson (Guangzhou) Ltd.
MEDA Co., Ltd.
MERCK & CO., Inc.
MicroPort Medical (Shanghai) Co., Ltd.
National Shanghai Center for New Drug Safety Evaluation and Research
Northeast Pharmaceutical Group Co., Ltd.
Novartis AG
Novo Nordisk (Tianjin) Biotechnology Co., Ltd.
Sanjiu Medical & Pharmaceutical Co., Ltd.
Schering (Guangzhou) Pharmaceutical Ltd.
Science and Technology Park Ltd., Guangzhou University of TCM
Servier (Tianjin)
Shandong Jewim Pharmaceutical Co., Ltd
Shandong Luye Pharmaceutical Co., Ltd .
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd.
ShangBio Corporation
Shanghai Baijiayi Pharmaceutical Co., Ltd.
Shanghai Desano Biopharmaceutical Co., Ltd.
Shanghai Sankyo Co., Ltd.
Shanghai Shuguang Hospital
Shanghai Wansu Chemical., Ltd.
Shanghai Zingsun Pharmaceutical Technologies Co., Ltd.
Shenyang Research Institute of Chemical Industry
Shenzhen Food and Drug Administration
Shenyang Senwei Technologies Co., Ltd.
Shijiazhuang Pharmaceutical Group
Sichuan University - West China Hospital
Siemens Mindit Magnetic Resonance Ltd.
Siemens Shanghai Medical Equipment Ltd.
Sino-swed Pharmaceutical Co., Ltd.
Solomon Solutions Services
Summit Life Sciences Limited
Suzhou Novartis Pharma Ltd.
Tianjian Tasly Pharmaceutical Co., Ltd.
Tianjin SmithKline & French Labs Ltd.
Tuoren Medical Equipment Ltd.
T黇 Rheinland Group China
U.S.A. Inverness Medical, Inc. Shanghai Office
United Laboratories
URIT Medical Electronic Group Co., Ltd.
Whale Software Co., Ltd.
Wuhan Strong Electronics Co., Ltd.
Wuxi Huarui Pharmaceutical Co., Ltd.
WuXi PharmaTech Inc.
Wyeth Pharmaceutical Co., Ltd.
Xi'an Lijun Pharmaceutical Co., Ltd.
Xian-Janssen Pharmaceutical Ltd.
Zhejiang Hom-eland Pharmaceutical Industry Co., Ltd.
Zhumadian Huazhong Chia Tai Co., Ltd.
Zibo Xinhua-Perrigo Pharmaceutical Co., Ltd.
(Last update in 12-31-2007)