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Microbiology and Statistics

Microbiology is an imprecise science. Large standard deviations are inherent to microbiological methods and often do not reflect the precision of the technician or the precision of an instrument. Guidelines for the of validation alternate methods try to account for this imprecision, but often do not go far enough. Unfortunately, this can put the QC lab in the position of failing perfectly good alternate methods. One has to ask, would the compendial test pass the guidelines for validation? The fact is, compendial methods would fail at an unacceptably high rate if they were held to the same standards.

Listen to this presentation to learn about two particular aspects of validation: precision and accuracy. Data generated in our own lab and in QC labs from large pharmaceutical companies will be used as examplars.

First Name *

Last Name *

Company Name *

Job Title *

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How do you perform Micro QC culture tests today *

We are a manual, growth-based test
We use an alternative method, but it has limitations
We use a growth based rapid method, but it is labor intensive

How important are productivity tools such as Six Sigma and Lean to your business *

It is not something our company considers important
It is highly important in manufacturing, but not in the labs
It is highly important in both manufacturing and in the labs

What is your timeline for implementing a Rapid Microbial Testing technology in your Micro QC lab? *

Within the year
Before the end of 2013
Beyond 2013

RapidMicro

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Microbiology and Statistics