January/February 2017

Volume 37, Number 1

 

IN THIS ISSUE

Cover: The New Face of Leadership
Robin Kumoluyi, Johnson & Johnson’s Vice President of Quality Systems and Services talks about her career path, willingness to take chances, and determination to be a leader.

Feature: The Catastrophe of Drug Shortages in Pediatric Oncology
Pediatric hematologist/oncologist Dr. Yoram Unguru calls drug shortages “a national disgrace” that delay lifesaving treatments, and lead to patient deaths. Drug companies must be part of the solution, he says.

Special Report: YP Voices
We asked ISPE Young Professionals to share their perspectives on the pharmaceutical industry. We also caught up with former student poster competitors to see how that experience helped shape their careers.

TABLE OF CONTENTS

Editor's Voice

Message from the Chair

A YP State of Mind

COVER STORY

The New Face of Leadership
Pharmaceutical Engineering talks leadership and career development with Robin Kumoluyi, Vice President, Johnson & Johnson Quality Systems and Services

PEOPLE + EVENTS

A Quality State of Mind

  • ISPE and Pew Charitable Trusts Release Report on Drug Shortages
  • FDA Issues Revised Draft Guidance on Quality Metrics
  • ISPE 2017 Conference on Quality Culture and Quality Metrics
  • Quality Culture in Action at ISPE 2016 Annual Meeting

Barcelona Has It All

ISPE Europe Conference on Biotechnology

Brazil 2016 Annual Conference

Nordic Affiliate Annual Meeting

ISPE Biopharmaceutical Manufacturing Conference

2016 ISPE Facilities of the Future Conference

Q1 2017 ISPE Training Institute Courses

ISPE Guidance Documents: Coming Soon

Meet Young Professional Jamie Sigmon

In Other Words

CAREER Q&A

Make the Most of Your Day at a Job Fair
David G. Smith, Principle Recruiting Partner, Biogen

FEATURES

The Catastrophe of Drug Shortages in Pediatric Oncology
Scott Fotheringham, PhD

Drug Shortages: Theory into Practice
John Berridge, ISPE Advisor, Regulatory Affairs

2017 PERSPECTIVES

Looking Ahead
What does 2017 hold in store? What will be the most important industry drivers? Pharmaceutical Engineering caught up with a few industry leaders during the ISPE 2016 Annual Meeting to get their perspectives. 

SPECIAL REPORT: YP VOICES

Where Are They Now?
Five student poster competitors talk about their career-shaping experiences

My First ISPE Annual Meeting
Chris Slevin shares his thoughts about the opportunities for YPs at the ISPE Annual Meeting

Standing in the Gray
A risk-based quality system is focused on continuous incremental improvements, says Tiffany Coleman

Making a Living, Making a Life
Wendy Haines has learned to view challenges and failures not as negatives, but as opportunities for improvement and better solutions

Advice from a Thriving Entrepreneur
Up-and-coming CEO Karthik Ramachandran says that networking connections can lead to partnerships that foster innovation

TECHNICAL ARTICLES

The History of Quality and the Evolution of the Modern Leader
Mary Foss and Andrew Deceuster

Process and Product Contact Surfaces in Bioprocessing
Albert Dyrness and Carl Johnson

CPV Signal Responses in the Biopharmaceutical Industry
Mark DiMartino, Abdelqader Zamamiri, Kevin Pipkins, Jim Heimbach, Eric Hamann, Syama Adhibhatta, Richard Falcon, Kevin Legg, and Robin Payne

Estimating Process Capability in Development and for Low-Volume Manufacturing
Kimberly Erland Vukovinsky, Fasheng Li, and Dawn Hertz

POSITION STATEMENT

Where Will New Antibiotics Come From?


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 © 2016 ISPE. All rights reserved.)

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