Presented by Dr. Karen Bossert, New Dates To Be Announced, in Kingston NY
Taking a product from research and development to commercialization can be a daunting task, particularly for the organization that is introducing their first product to the market. FDA 2011 Process Validation Guidance was designed to help companies understand the requirements for new products to be successful but still requires interpretation for implementation. This course is designed to understand the impact of 2011 Process Validation Stages 1 through 3 for lyophilized products and how to scientifically plan and manage these stages. Students will be given scenarios to troubleshoot to further reinforce their understanding of the course material. For more information on this course please Click Here.