Volume 29, Number 1

Table of Contents

Articles

Online Total Organic Carbon (TOC) as a Process Analytical Technology for Cleaning Validation Risk Management

by Keith Bader, John Hyde, Peter Watler, Amber Lane
This article offers an alternative method to cleaning validation using online total organic carbon analyzers to determine cleaning validation in-situ. Methods are compared with traditional laboratory analysis.

Using Visible Residue Limits for Cleaning

by Richard J. Forsyth
This article presents the use of visible residue limits. Parameters were defined, their ruggedness determined, and applications described.

Industry Interview Series: Senior Staff Members from China’s State Food and Drug Administration (SFDA)

by Robert P. Best, Robert W. Tribe, Paul N. D'Eramo, Cheryl Siow
In this interview, senior staff members from China’s State Food and Drug Administration share the latest developments and achievements of China’s activities in drug manufacturing and supervision of drug safety, and ideas for future potential cooperation with ISPE and other international organizations in the industry.

Beyond the Bell Curve: A Report on Managing Capital Project Risk

by Jeff Lukowski, Mark Bridgers
This report presents the results of the FMI/CMAA Ninth Annual Survey of Owners and provides insight into how companies with ongoing capital construction programs manage risks on projects.

Fundamentals of Bacterial Adhesion Applied Toward Infection Prevention: Focus on Two Case Studies

by Yatao Liu, , Joshua Strauss, Terri A. Camesano, Paola A. Pinzon-Arango
This article presents a fundamental understanding and practical application of bacterial adhesion, the first step leading to infections. This article specially focuses on two cases, cranberries and urinary tract infections, and implanted biomaterial infections.

Considering Outsourcing? Risks and Benefits for FDA-Regulated Firms

by Mukesh Kumar, PhD, RAC
This article is being reprinted with permission from the October 2008 issue of Regulatory Focus, the monthly publication of the Regulatory Affairs Professional Society (RAPS).

Attachment

Country Profile: China - Jan/Feb 2009

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