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
• 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
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.