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.
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.
