Monthly Member Gift January 2014

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Welcome to Your Free Monthly Gift Package from ISPE

Gift #1:

Pharmaceutical Engineering Knowledge Brief: How to Determine Rouge Limits to Initiate Derouging and Passivation
by Nissan Cohen
Download the Knowledge Brief

The pharmaceutical industry has been concerned about rouge for many years. This Knowledge Brief, written by internationally renown pharmaceutical water systems expert Nissan Cohen, explores how previous approaches to determining rouge limits and derouging and passivation strategies have been unscientific and prophylactic in nature, and outlines methods for using real science in these processes. Once you've read the Knowledge Brief, share your views in the comments on the related post over at ISPEAK, ISPE's official blog.
 

Gift #2:

Whitepaper: ISPE Proposals for FDA Quality Metrics Program 
by the ISPE Quality Metrics Working Group
Download Whitepaper

ISPE has been leading the charge to bring industry and regulators together to discuss quality metrics ever since the US FDA first brought the subject to the forefront of industry thinking in the Food and Drug Administration Safety and Innovation Act (FDASIA). At the request of FDA, the ISPE Quality Metrics working group has developed a whitepaper on potential measures of product quality, site operations quality and site systems performance. The recommendations contained in the paper stem from robust industry-FDA discussions facilitated by ISPE’s Quality Metrics working group. Download the paper to read the group's recommendations for current and future steps to help implement this critical FDASIA initiative.
 

If you have feedback regarding your monthly gift from ISPE, including suggestions for future content, please contact Debra Sher at dsher@ispe.org. Don't forget to review your Member Benefits on a regular basis to stay current and make the most of your membership!

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