Setting up a cGMP compliant Microbiology Laboratory

This webinar will help companies that are currently setting up a microbiology laboratory as well as current microbiology laboratories to evaluate themselves against the current practices.

Why Should You Attend:
Requirements for operating a microbiology laboratory to support cGMP manufacturing of drugs is more complex and has specific requirements when compared to that of a chemistry laboratory. There are significant expenses associated with maintenance and understanding of the industry expectations is a must.

Because of the inherent variability in microbial data, proper quality systems must be in place to help ensure the reliability and reproducibility of the results obtained from the laboratory. The quality systems required include control of media, control of test organisms, and control of equipment, proper aseptic technique and training of personnel. Equipment needs are also significantly different than that of a chemistry laboratory. Because results may be difficult to interpret due to the inconsistency of results (from lack of organisms lack of homogeneous distribution, environmental factors, etc.), procedures specific to microbial data may be required as well as more testing or environmental controls.

Attend this Webinar to have a through understanding of best practices related to programs required, the equipment needs, testing controls, trainings and OOS investigations for setting up a microbiology laboratory.

Areas Covered in the Seminar:

Microbial testing performed by a microbiology laboratory to support manufacturing.
Equipment need.
Testing controls.
Evaluating results.
OOS investigations.
Training.

Who Will Benefit:

This webinar will help companies that are currently setting up a microbiology laboratory as well as current microbiology laboratories to evaluate themselves against the current practices.
Microbiology personnel
QC microbiologist
QC managers
Quality Assurance

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