The Center for Professional Advancement, Boca Raton, FL
October 29-31, 2007
Who Should Attend:
The course is designed for professionals in the medical device, biotechnology and pharmaceutical industries including:Those needing a basic knowledge of microbiology as it affects their function
Microbiology personnel who wish to get updated on new, more reliable rapid testing, monitoring and identification methods
Audit personnel needing more background in the microbiological aspects to be considered when auditing Personnel with little background in microbiology, such as manufacturing, validation,and facilities staff that need to gain a better understanding of how to better deal with microbiological issues
Description:
This course will present information on microbiological control in manufacturing, laboratory auditing and sterilization. The course will also cover ISO, EP, BP, USP, AAMI and U.S. FDA documents and guidelines. Validation of sterilization processing will be discussed and case studies will be presented. Environmental monitoring programs will be discussed in depth. Design and testing of product packages for sterility assurance will be covered via case studies. All aspects of microbiological control will be covered. Microbiological testing schemes will be presented and the key aspects of GLP/cGMP will be reviewed. You are invited to bring transparencies of monitoring programs, procedures, flowcharts, etc., for discussions during the case studies on the third day.
|
|