Speaker Biography
Gilbert Salud
Gilbert Salud is the Acting Team Leader for Biotech Manufacturing in the Office of Compliance at the Center for Drug Evaluation and Research in FDA. He has been instrumental in facilitating the transition of and development of policies for the transferred CBER/CDER biotech products. As a group leader for the biotech team, Salud is responsible for conducting and managing CMC regulatory reviews for original Biologics License Application, New Drug Applications and Application Supplements. In addition to his review responsibilities, he is also the lead investigator on Pre Approval Inspections. Salud has worked with the review of medical device applications (Pre-market Approvals and 510Ks) and compliance cases at FDA's Center for Device and Radiological Health as a Compliance Officer. Prior to joining FDA, he spent several years managing validation projects for contract validation companies serving the pharmaceutical and biotechnology industry. Salud has BS in biology/chemistry and a MS in chemical engineering.