November / December 2016

Cover: Maurice Parlane, 2016 Max Seales Yonker Member of the Year
Pharmaceutical Engineering sits down with Maurice Parlane to talk about his career, his company, ISPE, and being named 2016 member of the year.

Special Report: Quarterly Report: Quality Culture
Our first report on quality culture features industry insight on leadership, Gemba walks, the role of behavior, and FDA’s quality metrics research. 

Technical Article: Current Challenges in Implementing Quality Risk Management
James Vesper and Keven O’Donnell

Technical Article: Distribution Quantification of Synthetic Amino Acid Oligomers
Ke Wang, Fangfang Liu, Stéphane Caron, and Kimberly Erland Vukovinsky

Technical Article: Quality Culture Case Study: The Importance of Understanding the Process
Norman Howe and Nicole Leitz

NOTE: Pharmaceutical Engineering articles are not to be posted on any website, blog site or page, or any other internet site without prior permission from ISPE. (Copyright © ISPE. All rights reserved.)