Monthly Member Gift August 2012

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Welcome to Your Free Monthly Gift Package from ISPE

These gifts will be available to you through 30 September 2012.

"Safe Supplies: Technology Approaches to Thwarting Disruption"Download Presentation ( 119 KB)
Sharon Flank, PhD, CEO, InfraTrac, USA
From the Designing, Implementing and Maintaining Pharmaceutical Supply Chains Conference

This presentation, from the top-rated session at the recent Supply Chain Conference in Baltimore, Maryland, discusses various methods for ensuring a safe pharmaceutical supply chain. Learn about several key considerations that companies must keep in mind when dealing with supply chain safety and technologies developed to help better safeguard raw materials and finished products. View now ( 119 KB) !

Process Validation Concept Paper Topic 1 – “Stage 2 Process Validation:  Determining and Justifying the Number of Process Performance Qualification Batches”Download Paper ( 1 MB)
Mette Bryder (Lundbeck), Harold Etling (Eli Lilly), Jeff Fleming (Pfizer), Yanhui Hu (Abbott),
Peter Levy (PL Consulting)
From the ISPE PQLI Process Validation Implementation Team

This discussion paper addresses practical application of the lifecycle approach to process validation to selection of the number of PV Stage 2 batches. Three approaches utilizing science and risk and an example are included. View now ( 1 MB) !

The State of Quality by Design for GenericsDownload Article ( 385 KB)
Chris Potter, ISPE PQLI® Technical Project Manager and CMC Pharmaceutical Consultant
From the ISPE-EGA Meeting on QbD for Generics and Pharmaceutical Engineering Magazine

Go behind the scenes of the recent joint meeting between ISPE and the European Generics Association (EGA) to discuss the application of Quality by Design (QbD) to the design and development of generic medicines. This article contains background on the creation of the meeting and discussion highlights. View now ( 385 KB) !

Featured Member Benefits

Voting and Volunteering
ISPE's initiatives and leadership have a major impact on the pharmaceutical industry through setting best practices, leading industry thinking and being on the front lines of collaboration with global regulatory agencies. Your ISPE membership is your key to being a part of these activities—ONLY ISPE Members can volunteer to participate in ISPE initiatives and vote for and serve on the International Board of Directors. Through volunteering and voting, you can have a personal say in the direction of the Society, and by extension, the pharmaceutical industry.

Learn more about volunteering and the International Board of Directors election.

If you have feedback regarding your monthly gift from ISPE, including suggestions for future content, please contact Rosemary Jones at 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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