Ⅰ．Benefits of the training
Introduce the newest regulation and standard requirements in quality management process of sterility testing
Present different kinds of methods of sterility testing in detail in order to improve the quality management level and efficiency in the field of medical device.
in the training, it includes case study, analyzing and discussing so that it can be efficient.
Ⅱ. Training objects:
Staff who are engaged in production supervision , routine control and inspection in medical device regulator.
Staff who take part in production management, quality assurance , quality control and testing in medical device enterprises.
People who want to know relevant skills
Ⅲ．Training content
Choice , usage and maintenance of ha***are which is needed by Routine microbiological test.
Types of medium and their choice and usage
The choice of sample preparation and application
The choice and confirmation of experimental method
The transfer technology of microorgani*** and cultivate microorgani***s system
Observation methods of training results
Testing result reco*** and basic content of the testing report
Experiment quality control
The initial pollution bacteria inspection
Pyretogenic testing
Pure water testing
sterility testing
physical operation
Ⅳ．Training time and place:
Time: September 2012
Place: Guangzhou,
Ⅴ．Introduction of organizers
GuangdongMedical Device Quality Supervision and Test Institute
Guangdong Medical Device Quality Supervision and Test Institute was founded in1988, directly affiliated institution of Food and Drug Administration, the only national medical equipment inspection institution in southern China as well as the medical device equipment quality supervision and inspection laboratory which is appointed by the State Food and Drug Administration. It performs the duties of Guangdong province quality supervision and medical equipment testing stati*** and Guangdong medicine packing product quality supervision and inspection offices. It is also resp***ible for the quality supervision and inspection in the state, provinces and districts, at the same time , it is the national compulsory CCC certification of products designated testing laboratory and inspection laboratory of CE authentication products authorized by Germany TUV PS
Medical Device Quality Management Committee, China Quality Association for Pharmaceuticals
Medical Device Quality Management Committee, China Quality Association for Pharmaceuticals is a commonweal social organization which is registered by Ministry of Civil Affairs. As the assistant of developing medical device quality management, it is a science and technology organization which is taken part in by people who focus on the management of medical device , as well as to help government contact with pharmaceutical enterprises. It is undertaken by China Quality Association for Pharmaceuticals and it is affiliated to Guangdong Medical Device Quality Supervision and Test Institute.
O***unda Medical Device C***ulting Organization
O***unda Medical Device C***ulting Organization which focuses on professional c***ulting in the field of medical device , founded in 2004, has set up seven wholly owned subsidiaries in Guangzhou, Beijing, Shanghai, Suzhou, Shenzhen, Jinan and America. We are able to provide fully soluti*** to medical device manufacturers, including marketing research, technical and capital services, workshop selection and design , clinical trail , quality system establishment , third party audit and global marketing approval.
The training certificate is issued solely by Guangdong Medical Device Quality Supervision and Test Institute, Medical Device Quality Management Committee, China Quality Association for Pharmaceuticals and O***unda Medical Device C***ulting Organization.