When a company is tasked with ensuring the safety of the nation’s food supply, it is imperative that laboratory methods needed to support regulatory compliance, investigations and enforcement, meet the highest analytical performance standards appropriate for their intended purposes, according to the FDA. For the development of standardized validation requirements for all regulatory methods used to detect microbial pathogens and in your laboratories, it is critical that you continue to meet the highest standards possible.
Why You Should Attend
Join this virtual boot camp, where food safety expert Angela Bazigos will cover the latest FDA thinking and guidance documents to assist you in re-establishing the requirements that need to be fulfilled in the evaluation for microbial methods used in your testing laboratories. This boot camp will also re-establish performance evaluation (verification and validation) criteria, necessary for the use of commercially-available diagnostic test kits and platforms.
Angela will describe the FDA’s evaluation criteria for methods to detect, identify and quantify all microbial analytes that may now be, or have the potential to be, associated with foods and feeds, i.e. any microbiological organism of interest (target organism) or the genetic material i.e. DNA, RNA, toxins, antigens or any other product of these organisms.
This boot camp will cover the methodologies that are also used by FDA labs. FDA applies them to education, inspections, data collections, standard setting, investigation of outbreaks and enforcement actions.
CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers & Public Health Services companies. Positions include Chief Compliance Officer at Morf Media, Director of QA, MIS Director. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA. Patent on speeding up software compliance. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom. National Trainer for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for LifeSciencesMore Info