Workshop Description: Method Validation Fundamentals
Dr. Barker will present on the topic of method validation. As formulations, methods, and technologies increase in complexity, it continues to be necessary to ensure methods are appropriately validated for their intended purpose, comply with regional and global guidance, and are capable with respect to approved product specifications. This presentation will provide an overview of current guidance and will discuss method validation scenarios for multiple technologies and properties that include references to literature, guidance, and compendia.
Presenter: Amy Barker, Ph.D
About our presenter:
Amy R. Barker, Ph.D. received her bachelors and Ph.D. from the University of Toledo. She is currently a Senior Quality Advisor, Global Quality Laboratories for Eli Lilly & Company where she has responsibility for assuring small molecule commercial product methods are compliant and robust, including technical responsibilities for new product commercialization and investigations. Dr. Barker has expertise in separation sciences, dissolution, cleaning analytical strategies, method development, method validations and method transfers. She participates in all stages of analytical lifecycles, from development and commercialization of new products, transferring methods to international laboratories, providing methods to compendial organizations and working with global regulatory agencies.
Dr. Barker serves as a volunteer for a compendial monographs expert committee as well as the Quality Advisory Group for the United States Pharmacopeia. She has authored, co-authored, and presented technical papers, seminars and workshops on the topics of method validation, troubleshooting and transfers, capillary electrophoresis, and dissolution.
This link will connect you to the recorded presentation from the meeting.