Medical Device Sterile Inspectors Training

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 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

IV. Training time and place:
Time: September 2012
Place: Guangzhou,