Monthly Member Gift October 2010

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Make the Most of Your Membership

ISPE Members deserve the very best -- which is why we've put together this FREE monthly gift email just for you! This month, we're highlighting resources that relate to Product Quality Lifecycle Implementation® (PQLI®), ISPE's Global Industry Initiative for a Practical Approach to implementation of ICH guidances Q8 (R2), Q9, Q10, and the future Q11. Enjoy!

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FREE PQLI Good Practice Guide for Members
This month's FREE Member gift is truly exciting and beneficial. The highly-anticipated first PQLI Guide, titled ISPE Product Quality Lifecycle Implementation (PQLI) Guide: Overview of Product Design, Development, and Realization: A Science- and Risk-Based Approach to Implementation, will be officially launched on 1 November 2010. As our special gift to Members this month, the Guide is available to you right now, two full weeks ahead of the official launch date, and absolutely FREE (cost is $25 for non-Members).

This document is the first in a series of ISPE Good Practice Guides (GPGs), and addresses product and process development, transfer to, and establishment of, commercial manufacture using science- and risk-based approaches. It uses ICH guidelines Q8 (R2), Pharmaceutical Development, Q9, Quality Risk Management, and Q10, Pharmaceutical Quality System as a basis, together with other relevant ICH guidelines.

Being among the first to receive information on revolutionary industry concepts is just one of the many benefits of being an ISPE Member.

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Want to learn more about PQLI? ISPE has a number of resources available on the subject, just for Members. A great place to start is by viewing the Members-only webinar PQLI 101: Vision, Status and Next Steps, which provides an overview of PQLI, from its history to its current status, as well as where the program is heading. This fundamental-level course, led by CMC Consultant and PQLI Technical Project Manager Chris Potter, is a must-see for any industry professional in a quality discipline. To help expand your PQLI knowledge, we're offering this webinar FREE to all Members.

Another excellent way to learn more about PQLI is by reading the Pharmaceutical Engineering article, PQLI Roadmap: Product Design, Development and Realization, a Science- and Risk-Based Approach to Implementation. Written by Chris Potter and John Berridge with contributions from the PQLI team, the article gives a top-level roadmap to understanding PQLI, including an overview of the application of Quality by Design (QbD) to product realization.

Free webinar: Process/Product Development: Product Quality Lifecycle Initiative (PQLI) 101: Vision, Status and Next Steps. FREE for Members.

Additional Resources:

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Volunteering with ISPE is one of the biggest rewards of Membership. Truly, it is difficult to overestimate the impact you can have as an ISPE Volunteer. The Volunteers involved with the PQLI program, for example, have created a new movement within the pharmaceutical industry, leading to changes that affect the entire pharmaceutical manufacturing community. At the same time, these Members have grown their own personal communities by meeting and working with new people to develop PQLI. Read an insider’s account of the PQLI volunteer group , written by Stephen Tyler of Abbott.

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Everyone is aware that the pharmaceutical industry has been changing in the past few years. If those changes have caused you to search for a new job – or to think about whether you may need to change positions – you should be familiar with the Position Postings and Job Boards ISPE has gathered. Check out our Job Lists for jobs available exclusively to ISPE Members. You’ll also find lists of job boards from around the world. In addition, ISPE's Career Solutions site provides you with many of the tools you need to help you find the right job.

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Keeping up with the latest regulatory news is a must for staying at the top of your profession. Did you know that ISPE has resources devoted solely to making sure our Members have the latest information bulletins from the FDA and other important industry regulators? This information is available exclusively to ISPE Members, and is among the many benefits you receive with your Membership.

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Did you find this month's FREE Members-only content valuable to you? Do you have ideas for what you'd like to see discussed in the future? We want your feedback, both positive and constructive. Please let us know how we can better serve your needs by sending an email to

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