Pharmaceutical Manufacturing Preview

July/August 2009 Issue Preview

Ad Closing: July 8, 2009 | Material Closing: July 15, 2009

Cover Story
Training and Staffing: The Workforce You Want vs. the One You Have?
Why shouldn’t they be one and the same? Can they be? Experts from academia, government and the industry discuss key training and educational needs, best practices, and issues shaping the future.

Operational Excellence
FMEA: Making it Work
An in-depth look at how Lonza and other pharma companies are realizing substantial bottom line benefits by utilizing failure modes and effects analysis (FMEA). The article will also examine the Hirano Method, a specialized form of FMEA, and its application in pharmaceutical manufacturing.

Process Control
Calibration at BMS
How a different method of analytical and process instrument calibration is making a difference at BMS, and improving control of milling operations and particle size reduction.

SPECIAL SECTION ON OUTSOURCING
Ensuring QbD Extends to Contract Research and Manufacturing Partners
Best practices from Russ Somma, president of SommaTech, LLC; Rakesh Kishan, president of UMS Advisory, Inc.; and Ron Perry, Co-Champion, Wyeth Supplier Quality Excellence Team. The section will also examine trends affecting contract manufacturing.

Packaging
QbD Doesn’t Stop with the Drug: Optimizing Pharmaceutical Packaging
Peter Schmitt, founder of the consulting group, Montesino Associates, discusses the best ways to apply Quality by Design concepts to drug packaging, so that efforts for drug and delivery format and packaging go hand in hand.

Plant Operations
RFID on the Plant Floor
We often hear about RFID’s potential in securing the pharma supply chain, but it is already playing a growing role at many plants, in ensuring security and minimizing error. Our editors examine trends and best practices.

Unit Operations
HAPIs – Minimizing Environmental Input
As potency continues to be a key drug development driver, highly active pharmaceutical ingredients are becoming common in more manufacturing environments. Engineering and design experts share best practices for ensuring workplace safety.

UPFRONT – Pharma e-Pedigree Update

Contract Manufacturing
Outsourcing IT Services


Advertising & Editorial Information

For advertising information contact your district manager or Tonia Becker, Publisher, at 630/467-1300 ext. 455, tbecker@putman.net. Send insertion orders to Anna Marie McCann at Pharmaceutical Manufacturing, 555 W. Pierce Rd., Suite 301, Itasca, IL 60143; fax 630/467-0197.

For editorial information, contact Agnes Shanley, Editor-in-Chief, at 630/467-1301, Ext. 410, ashanley@putman.net.

Pharmaceutical Manufacturing