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    • FDA Issues Revised Draft Guidance on Quality Metrics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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