Author: Washington M. Osiro

Washington is part of Neozene’s internal team of quality and regulatory subject matter experts. He has over 20 years’ experience in the medical device, biotech and compounding pharmaceutical sectors as an Operations, Quality Systems, Regulatory and R&D professional. Washington earned his Bachelor’s Degree in Political Science from UC San Diego’s John Muir College. He is currently pursuing his MBA with a focus on Public Administration at Notre Dame De Namur University and plans to graduate by Fall 2018.

Navigating the Quality Assurance and Regulatory Landscape in Compounding Pharmacy
May 10, 2017
By Washington M. Osiro

Contributors Author: Washington Osiro, M.B.A (cand.) Reviewers: Devin McElroy, Ph.D. (cand.), CSSGB, CQA Sormeh Mahjouri, MPH Introduction This article provides an overview of the compounding pharmacy industry given reports of adverse events[1], some resulting in patient deaths, that has befallen it. The summary is designed to provide compounding pharmacy management a brief history and state-of-the-industry overview. Between understanding the industry’s history and its current state, management will be better-positioned to formulate a strategy on how to navigate the quality assurance and regulatory landscape in the process assure patient safety by