This two-day course provides comprehensive and up-to-date knowledge of assay validation for quality assurance and control of pharmaceuticals, biopharmaceuticals, and biologics. The course covers regulatory expectations regarding validation as contained in U.S. and international regulations. The guidelines of the International Conference on Harmonization (ICH) will receive special attention. This course will prepare attendees to plan and execute effective, compliant method validation plans. There will be an opportunity to apply what you have learned in a validation workshop.