Microbiologists play a prominent role in sampling, testing, analyzing and interpreting results for products that are used by millions of individuals around the world.  For products manufactured under cGMP guidelines, the microbial criteria used to release them into the market are usually quite clear – the product either meets the specifications and is released, or does not meet them and is rejected.  Although the specifications may be clear, often the results are not, and microbiologists face the task of deciding whether to accept or reject the product.  For example, what happens when an objectionable microorganism is found?  Is the product automatically rejected or can a risk analysis be conducted before making a final decision?  This is what microbiologists and managers face every day: making a very difficult decision without any guidance to support their position.  Many times the microbiologist is alone in a stormy sea of corporate executives, managers and regulators.

This conference is designed to help microbiologists, and their management teams, interpret Microbial Data Deviations.  It will provide pragmatic alternatives to automatically rejecting products, as experienced by industry veterans who have been there, done that.

This conference will be moderated by Frank Settineri who is the founder and president of Veracorp LLC. He has more than 30 years of experience in the pharmaceutical industry.   Frank will lead a team of nationally known experts over the course of the two days, allowing all participants opportunity to address their concerns with several experts present.