March/April 2016

Volume 36, Number 2

 

IN THIS ISSUE

Compliance Matters

Thomas Cosgrove, director of FDA’s Office of Manufacturing Quality discusses his work to protect patients from the risks posed by poor drug quality. Data integrity, he says, is a big part of the solution.

Getting It Right

Joe Famulare, ISPE Board Chair, weighs in on compliance, quality metrics, and how new technology is changing the industry. He also sat down with a panel of medical experts as part of an national radio broadcast to discuss drug shortages.

Biopharma Dominates Smartest Companies List

Thirteen life sciences companies were among MIT Technology Review’s “50 Smartest Companies for 2015,” a much more impressive showing than in previous years, mostly for pioneering technologies that can tackle challenging illnesses.

Data Integrity

Our six-part special report explores this multifaceted subject, describing the desired state, identifying red flags, and enumerating best practices. Our experts define the strategies that drive prevention, detection, and response: administrative and technical controls, effective review processes, critical success factors, and corporate training to encourage integrity.

TABLE OF CONTENTS

Cover Story

Thomas Cosgrove, FDA, OMQ: Compliance Matters. Get It.

ISPE News

  • NPR Discusses Drug Shortages with ISPE Board Chair
  • ISPE and Pew Launch Joint Project
  • ISPE Announces FOYA 2016 Category Winners
  • Boston and Beyond: Japan Affiliate Revisits the United States
  • Strength in Numbers
  • Meet Your New 2015-2016 Executive: Part 2
  • Appointments
  • Guidance Documents

YP State of Mind

Three Goals for YP Development

Young Professionals

Meet Young Professional Maša Ivanković

Profile

ISPE Pacific Northwest Chapter

Features

  • Millennials: Searching for Meaning … and Willing to Move On
  • Joe Famulare: Getting It Right
  • Biopharma Dominates Smartest Companies List

Special Report: Data Integrity

  • Throwing People into the Works
  • Implementing a Corporate Data Integrity Program
  • An Ounce of Prevention
  • How Good Is Your Data?
  • Big Brother Is Watching
  • Doing the Right Thing

Technical Articles

Enhancement of Solubility and Stability of Itraconazole by Formation of Solid Crystal Suspensions Using Hot Melt Extrusion
Jaywant Pawar, Vinod S. Gokarna, Vineeta D. Deshpande, and Purnima D. Amin

The History of Cleanroom Garments
Jan Eudy

Association of QbD Tools with Biopharmaceutical Classification Systems
Mehtap Saydam

Quality Risk Management for Legacy Products in CMOs
Humberto Vega and Ricardo Rivera

Back Page

Quest for the Magic Bullet


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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