September 2010 Issue Preview
Ad Closing: August 13, 2010 | Material Closing: August 20, 2010
Cover Story
Survey on Pharma's Use of Automation and Control, PAT and QbD
Readers share their strategies for applying process control, MES and other systems, while discussing their interest in, and experiences so far, with Process Analytical Technologies (PAT) and Quality by Design (QbD).
Data Management and IT
Paul McKenzie on Integrating Data, From Lab to Patient
In the two and a half years he has been at Centocor, Paul McKenzie, global head of pharmaceutical R&D and manufacturing sciences for J&J R&D, is applying some of the concepts he initiated at BMS, to manage diversity of platforms and delivery systems, and optimize results for the patient. In this exclusive interview, he discusses Centocor's Lab-to- Patient program and its IT and control underpinnings.
Quality by Design
Is Your Organization Ready for Quality by Design?
Bill Schmidt from Tunnell examines what makes any drug manufacturer "ready" to implement Quality by Design, successfully. If you aren't, you'll want to fix some infrastructural issues, outlined in this article.
Outsourcing and Contract Manufacturing
Purchasing Controls: Geting Them Right
Braulio Ortiz and Michael Neaves of the consulting firm BioTeknica examine FDA 483's that have focused on purchasing controls, how to establish clear guidelines and stay out of trouble.
Quality Assurance and Control
Smarter Calibration
Consultant Dan Collins elaborates on his smart calibration concept, and how to make a case for it to senior management.
Regulatory Compliance, QA and QC
Know Your Bugs: A Survey of Microbial ID Methods for Cleanroom Management
Consultant Pascal Yvon of BioQTforum shares insights into Microbial Measurement systems and other methods that are now available to identify problem microbes, how well they work and how they're being used.
Upfront - Supply Chain Management
Plant and Data Security
An update on the issues.
Leading Edge
Robotics on the Plant Floor
Editors survey the scene.
Advertising & Editorial Information
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For editorial information, contact Agnes Shanley, Editor-in-Chief, at 630/467-1301, Ext. 410, ashanley@putman.net.
