Robert L. Iser | AIChE

Robert L. Iser

Robert has been with the Office of Generic Drugs since 2003. He is currently Acting Director of the Division of Chemistry IV. Since joining OGD, Robert has been involved in numerous committees and working groups including the Question Based Review (QbR) Working Group and the OGD Education and Training Committee. He has provided guidance to industry as part of the faculty for the GPhA ANDA Basics Course; and has presented on CMC topics at a variety of workshops and conferences. Robert has co-authored several articles on QbR lessons learned and common deficiencies in ANDAs intended to provide clarity and transparency to the generic industry with regard to the OGD CMC review process. Prior to joining OGD, Robert spent seven years in the pharmaceutical industry. His industrial experience includes implementation and maintenance of quality systems, analytical method and procedure development, and the support of manufacturing process scale-up and validation.