Over the last couple of years there have been significant changes in the regulatory requirements for elemental impurities testing for drugs and biologics. Understanding the requirements, how and when to implement the testing and setting appropriate specifications have continued to cause confusion within the industry. Companies continue to receive regulatory feedback/questions from the FDA during IND/NDA/BLA reviews resulting in potential delays to their developmental programs.
This short course is associated with the August Land O Lake Pharmaceutical Analysis Conference.