Course offering number:0905-401
Course ID:
902
Microbiological Control and Validation
May 18-20, 2009
Burlingame, CA
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.