How to Build and Maintain an Effective Pharmaceutical Quality Management System

About Ajaz S. HussainHussain

Dr. Hussain worked as an academic at Ohio Northern University and the University of Cincinnati progressing to a tenured associate professor. In 1995 Dr. Hussain moved to the US Food and Drug Administration (FDA) where he served in various positions before becoming deputy director of its Office of Pharmaceutical Studies in 2000. He also held a Senior Biomedical Research Scientist position. He is widely recognized for his leadership of several FDA initiatives such as Process Analytical Technology and Pharmaceutical Quality for the 21st Century. Following a ten-year career at FDA Dr. Hussain served as Vice President and Global Head of Biopharmaceutical Development at Sandoz AG where he was responsible for development and regulatory submissions of biosimilars follow-on proteins and complex generic products. He also served as Vice President Next Generation Product Assessment and then as Chief Scientific Officer at Philip Morris International in Switzerland developing strategies and systems for advancing development programs on plant-based vaccines and products for tobacco harm reduction. In 2012-2013 Dr. Hussain became President Biotechnology and Chief Scientific Office at Wockhardt Ltd before founding his own consulting company Insight Advice and Solutions LLC in July 2013. He is a Fellow of the American Association of Pharmaceutical Scientists and of the Swiss Society for Pharmaceutical Sciences and recipient of several FDA and professional association awards. He has co-authored numerous scientific publications in the area of pharmaceutical science and holds several visiting professorships.