July/August 2016

Volume 36, Number 4

 

IN THIS ISSUE

Cover: Reimagining Medicine

Novartis CEO Joseph Jimenez sits down with Pharmaceutical Engineering to discuss the rapidly changing health care landscape, the role of R&D, and how the industry can develop long-term sustainable models.

FEATURES

The Real Cost of Poor Data Integrity

James Davidson of Lachman Consultants talks about the impact of GMP data integrity breaches and the costs of regulatory actions such as Warning Letters and import alerts.

JHL Biotech: From Start-Up to cGMP Manufacturer in Less Than Three Years

JHL Biotech has grown from a start-up to a certified cGMP pharmaceuticals manufacturer in three short years. Nick Kotlarski, VP Validation and Engineering, gives us the backstory.

SPECIAL REPORT

Supply Chain Manufacturing

  • Jim Curry, CEO of OpStat Group, explores the intersection of globalization, data integrity, and ISPE’s Operations Management Good Practice Guide.
  • The Operations Management Guide team leaders Jim Curry; Giuseppe Ravizzini, Group Engineering and Maintenance Manager, Recordati Group; and Marzio Mercuri, Technical Operations Director, Polpharma Group; talk about their new GPG and soon-to-be released survey of industry best practices.
  • David Churchward, Expert GDMP Inspector at MHRA, explains how regulators encourage a culture of data integrity.

TABLE OF CONTENTS

Editor's Voice

Cover Story

Reimagining Medicine
Joseph Jimenez, CEO, Novartis

ISPE News

  • General Session on Drug Shortages Reveals Progress
  • China Annual Spring Conference
  • Highlights from the 2016 ISPE/FDA/PQRI Quality Manufacturing Conference
  • FOYA Ceremony Highlights Drug Shortages Prevention Efforts
  • ISPE Releases Wave 2 Quality Metrics Report
  • The 25th Anniversary of GAMP®
  • ISPE Guidance Documents Coming Soon
  • Meet Alan Levy: ISPE’s 2015 Member of the Year

Affiliate Profile

Singapore Affiliate: A Leading Force in Southeast Asia

Feature Stories

The Real Cost of Poor Data Integrity in Pharmaceutical Manufacturing
Jim Davidson, Lachman Consultant Services

JHL Biotech: From Start-Up to cGMP Manufacturer in Less Than Three Years

In Your Opinion

Regulatory Harmonization Depends on Global Industry Connectivity
Roger Nosal, Vice President, Head of Global Chemistry, Manufacturing, and Controls, Pfizer Inc.

A YP State of Mind

How to Create a YP Start-Up Network
Robert Landertinger, Chair, ISPE Young Professionals Committee

Young Professionals

Meet Young Professional Tiffany Coleman: An Advocate for Diversity

Interview

David G. Smith: A Talent Acquisition Perspective

SPECIAL REPORT: SUPPLY CHAIN MANUFACTURING

  • We Do It to Make Medicine Available Anywhere in the World
  • Moving the Needle Forward: Operations Management and the Supply Chain
  • Beyond Compliance: How Regulators Encourage a Culture of Data Integrity

TECHNICAL ARTICLES

A Risk-Based Approach to Clinical Research: Solving Problems Before They Occur
Patricia Santos-Serrao

CPPM for Effective Multivariate Risk Modeling for Life Cycle Management
Matej Janovjak, John Cunningham, Adam Fermier, Steve Mehrman, and Roger Holenstein

Back Page

The Color of Drugs


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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