Steven A. Ostrove, Ph.D.

Specialties: Manufacturing, Regulatory, R&D

Steven A. Ostrove, Ph.D.

Steven A. Ostrove, Ph.D., has been involved in the Bio-Pharmaceutical business for over 35 years and is an invited course leader, lecturer and guest speaker for both national and international conferences.

In 1999, he opened Ostrove Associates, Inc. (OAI) – a validation, compliance and regulatory-affairs consulting company – to provide consulting services to both major pharmaceutical/biotechnology companies and small, start-up companies.

Previously, Dr. Ostrove worked as Senior Technical Specialist in the Technical Service Department of Pharmacia Biotechnology. He also served as Senior Director of Validation and Regulatory Affairs with a number of major design/build engineering companies.

In addition, Dr. Ostrove has also served as an adjunct professor of Pharmaceutical Engineering for Validation and Regulatory Affairs for the New Jersey Institute of Technology and as an adjunct professor of Biology for Kean College. He recently served as industry representative on an FDA advisory panel and as Acting Manager of Validation for a contract pharmaceutical/OTC manufacturer.

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Dr. Ostrove wrote a book in June 2016 titled, “How to Validate a Pharmaceutical Process, 1st Edition.” He has also published several book chapters, reference pieces and feature articles in a number of noted industry publications.

New FDA Guidance on Data Integrity, Classifying Co-Crystals