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.  However when the results are equivocal, products are frequently rejected because there are few precedents to help microbiologists interpret these data. 

This conference will be moderated by Karen Z. McCullough, Principal at MMI Associates, a consulting firm specializing in Quality Assurance issues.  She was most recently Senior Director of GMP Compliance at Roche Molecular Systems in Branchburg, NJ. She is acknowledged as a worldwide expert in the field of bacterial endotoxin testing (LAL). She is a Founder, Charter Member and Steering Committee Member for the LAL Users Group. Ms. McCullough's interest is in the convergence of science and compliance in the application of the principles and practices of cGMP to pharmaceutical microbiology. Ms. McCullough holds a B.S. degree in Bacteriology from Rutgers University and a M.S. degree in Molecular Biology from the University of Oregon. She has been involved in LAL testing and pharmaceutical microbiology for over 30 years.