A New Sandbox for ISPE and Its Members around the World Guest Editorial: The ISPE International Board of Directors has undertaken a strategic planning process for the years 2016–2019 and the fi nal strategic plan, now...
Future Factories for Manufacturing Flexibility Cover Story: In the 1970s, Nucor, which had been a nuclear energy company, decided to pivot vertically into steel manufacturing. It transformed traditional production...
Every Patient, Every Time Cover: by Andrew D. Skibo, Head of Global Biologics Operations & Global Engineering, MedImmune/AstraZeneca, and Chairman of the Board of Directors, ISPE Innovative Manufacturing Promotes Quality...
Celebrating Purpose, Intent and Innovation Guest Editorial: by John E. Bournas, President and CEO, ISPE FOYA Category Winners to be Honored at 2015 ISPE Facility of the Year Awards Banquet Managing the Design of a Single...
Drug Shortages and the Quality Debate by Carol Winfield and John Berridge Guest Editorial: Metrics that Give Voice to Quality by Joseph Famulare Conference Attracts 250 Enthusiastic Participants from Across Industry From...
Risk Assessment: Issues and Challenges by Joe Brady, PhD This article presents an opinion and a perspective on the practical application of risk assessment, on how to adopt a scientific approach to the risk management...
Facilities and Equipment Communication and Collaboration – Leadership Essentials in Pharmaceutical Project Management by Alandra Strain This article focuses on communication and collaboration as essential leadership...
Case Study: Applying a Risk-Based Decision Making Framework for Outsourcing by Bikash Chatterjee This article will discuss the application of Analytic Hierarchy Process (AHP) and Pairwise Comparison as a tool to assist...
Symposium Summary Report: The Use of Process Capability to Ensure Pharmaceutical Product Quality by Daniel Y. Peng, Richard Lostritto, Dafni Bika, Jean-Marie Geoffroy, Thomas Shepard, Brian Eden, Kenneth Coté, Alpesh...
Chemical and Media-Free Pretreatment for Biopharma RO – Electrolysis for Scale Precipitation and UV Dechlorination by Nissan Cohen and Shlomo Sackstein This article identifies the issues plaguing water systems with...
A Changing Landscape: Perspectives on Temperature Management for the Distribution of Non-Refrigerated Clinical Supplies Description by Dr. Nicole Assfalg, Ted Bradley, Tim Brewer, Sébastien Delporte, Kristen DeVito...
A Practical Approach to Managing Knowledge - A Case Study of the Evolution of Knowledge Management (KM) at Merck The Know-Houw and Know-Why: An Interview with Merck Implementing a Successful Knowledge Management Program...
Moving from Quality Control to Quality Assurance by Guy Wingate, PhD This article provides ways to implement an effective quality management system to allow manufacturers to meet their ethical and regulatory obligations...
Application of Single-Use Equipment for Buffer Storage and Distribution in Medium Size mAb Production Facility by Wilfried Kappel, Bhimasen Vadavi, Sanjay Lodha, and Daniel Karrer, PhD This article presents a hybrid...
Cleaning Validation for the 21st Century: Acceptance Limits for Cleaning Agents by Andrew Walsh, MS, Mohammad Ovais, MP, Thomas Altmann, Gr FC, and Edward V. Sargent, PhD This article presents currently suggested...
Labeling Pharma “Green” and Compliant in a Track and Trace World by Dana Buker, David Loy, and Harini Pillalamarri This update presents a discussion of the current regulatory landscape and how compliance and a “green”...
Compliant Cloud Computing – Managing the Risks by David Stokes This article presents pharmaceutical business process owners with an explanation of what cloud computing is, how it differs from traditional Information...
Establishing and Managing a Vendor Network for Clinical Supply Manufacturing Services by Francis Dumont and Sandra Onorato This article presents some essential operational and evaluation aspects of the Request for...