October 15, 2010 All-Day Event hosted by Lilly
The October All-Day Event will begin with registration at 8:00 am and end at approximately 4:00 pm. It will include a catered lunch at noon. (AGENDA) The following topics will be discussed: Incoming Bombshell: FDA’s New Process Validation Guidance, Process Validation – Incorporating Quality Design and Risk Management: A Case Study, A Case Study of Process Development for a Lyophilized Vial (Manufacturing Process: Lab Trials, Up-Scaling, Clinical Manufacturing, and Process Validation), A Case Study on Registration and Stability Batches of a Biologic Drug Product, and Current Trends in Process Validation. Click here for details and list of presenters.
Registration will end on Friday, October 8, 2010.