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.

   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

   Choice , usage and maintenance of hardware 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 microorganism and cultivate microorganisms system

   Observation methods of training results

   Testing result records and basic content of the testing report

   Experiment quality control

   The initial pollution bacteria inspection

   Pyretogenic testing

   Pure water testing

   sterility testing

   physical operation

Time: September 2012

Place: Guangzhou,

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 stations and Guangdong medicine packing product quality supervision and inspection offices. It is also responsible 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 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.

Osmunda Medical Device Consulting Organization which focuses on professional consulting 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 solutions 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 Osmunda Medical Device Consulting Organization.