GoingToMeet

Learn the steps needed to select, develop, optimize and validate biological assays to meet regulatory requirements in preclinical and clinical stages of biopharmaceutical manufacturing.

The lecture portion of this course outlines sensible approaches to develop reproducible bioassays using live systems and/or biologically derived reagents. These approaches are supplemented by guidelines to meet regulatory requirements according to their application. In addition, a workshop on writing validation protocols provides hands-on experience to cover these pivotal documents. You will also hear case studies that add relevance to the lecture materials and provide a launch point for class discussion.