COMBINATION PRODUCT TRAINING INSTITUTE

Education services, namely, providing classes and workshops in the field of drug delivery systems and medicated devices, FDA regulatory requirements, policies and rules for combination products and industry best compliance practices, design verification, design validation and human factors usability studies in combination product development, current trends and best practices with respect to combination products, FDA requirements for the submission of post-approval safety reports for combination products, FDA requirements for post-approval reporting of design and manufacturing changes to combination product applications, design and conduct of combination product stability studies, and combination product extractables and leachables; education services, namely, providing training in the field of design verification, validation and compliance with regulatory requirements of combination products