Virtual Course with Karen Zink McCullough, Owner, Principal Consultant at MMI Associates October 26th 9:30am – 1:00pm EDT

Every analytical method is subject to variability. For photometric (quantitative) endotoxin assays that reference a standard curve, perhaps the greatest variable is the accuracy and quality of the standard curve. Although the only current compendial “requirement” for the standard curve is linearity, this webinar will demonstrate that the impact not only of non-linearity but of slope and y-intercept on the quality of the curve and the accuracy of the test result. 

Your trainer
Karen Zink McCullough Owner, Principal Consultant at MMI

Karen Zink McCullough is the principal consultant at MMI Associates, a firm focusing on GMP and Microbiology in the drug, biologics, cell therapy, and medical device industries, with a speciality in the Bacterial Endotoxins Test (BET). Ms. McCullough was the first to publish on the use of the BET as a replacement for the rabbit pyrogen test for small volume parenterals. She has published over 50 articles and book chapters, and is the editor of the book, “The Bacterial Endotoxins Test: A Practical Guide.” She is a well respected international speaker on GMP and the BET. Ms. McCullough is chairperson of the LAL Users’ Group, is a United States Representative to Working Group 2, TC 209 for the revision of ISO 14698, and is a member of the United States Pharmacopeia Expert Committee on Microbiological General Chapters. She holds a Bachelor’s degree in Bacteriology from Rutgers University and a Master’s degree in Molecular Biology from the University of Oregon.

Karen Zink McCullough is the principal consultant at MMI Associates, a firm focusing on GMP and Microbiology in the drug, biologics, cell therapy, and medical device industries, with a speciality in the Bacterial Endotoxins Test (BET). Ms. McCullough was the first to publish on the use of the BET as a replacement for the rabbit pyrogen test for small volume parenterals. She has published over 50 articles and book chapters, and is the editor of the book, “The Bacterial Endotoxins Test: A Practical Guide.” She is a well respected international speaker on GMP and the BET. Ms. McCullough is chairperson of the LAL Users’ Group, is a United States Representative to Working Group 2, TC 209 for the revision of ISO 14698, and is a member of the United States Pharmacopeia Expert Committee on Microbiological General Chapters. She holds a Bachelor’s degree in Bacteriology from Rutgers University and a Master’s degree in Molecular Biology from the University of Oregon.