Monthly Member Gift July 2011 | ISPE

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Make the Most of Your Membership!

Welcome to your free monthly gift from ISPE! We want to help you take advantage of every possible benefit of your ISPE Membership. That's why we put together this special collection of knowledge, community, and professional resources just for you each month. Enjoy!

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FREE Webinar for Members

ICH Q11 has been an industry hot topic for years, and now that the guideline has reached the consultation phase, it's no wonder that the session on ICH Q11 was one of the most popular at 2011 Washington Conference. For this month's gift, we're giving you the chance to hear part of this hot topic session, absolutely FREE!

In this 60-minute recording, ICH Expert Working Panel member Betsy Fritschel gives you an insider's perspective on ICH Q11. Get a brief history of ICH and how Q11 evolved, delve into the specific content of the document, and learn how you can participate in the consultation phase and provide your comments to the ICH. Watch the webinar now!

FREE webinar: ICH Q11: Development and Manufacture of Drug Substances Status, Challenges, and Expectations
FREE to Members through 31 August 2011

PS - For more information on ICH Q11, view the guidance on the US FDA website, or visit the ICH website.

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Just last month, the European Commission (EC) released a new revision of EU GMP Annex 11 Computerised Systems, and consequential amendment of EU GMP Chapter 4 Documentation. These revisions have many companies struggling to understand exactly what has changed, and what will be required of them now that these new documents are in effect. The good news for you as an ISPE Member is that this month's knowledge resource is all about helping you make sense of the updated European Annex 11 guidelines. 

As your only official source for GAMP guidance, we're giving you an advance look at the official GAMP interpretation of the revised Annex 11. Learn what the GAMP Community of Practice (COP) sees as the most significant aspects of the revision, and get a section-by-section breakdown of what the revision means from a GAMP perspective. Read the ISPE GAMP COP Annex 11 Interpretation ( 279 KB), free now through 31 August.

This article comes from Pharmaceutical Engineering magazine. Pharmaceutical Engineering is a high-value benefit available only to ISPE Members, offering you important industry insight and news semi-monthly. As a reminder, you can browse back issues and search for specific articles by visiting the Pharmaceutical Engineering page on the ISPE website.

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Governed by a Steering Committee of Volunteer subject matter experts in numerous varied fields, ISPE’s Disposables Community of Practice (COP) was formed in 2007 to facilitate the use of single use systems by working towards the development of guidelines in conjunction with regulators, industry vendors, end-users, and engineering and design groups. The diverse community represents various disciplines associated with disposables such as vaccines, manufacturing, operations, aseptic processing (final formulation and final filing), R&D, process development, regulatory affairs, QA and engineering. Learn more about the Disposables COP .



In case you missed the news, the ISPE Board of Directors has approved the organization’s new strategic plan. The plan is the result of input from Members and volunteer groups all over the world, and you can read the highlights at the Strategic Planning website .

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For this month's Profession resource, we're going to let you in on one of ISPE's best-kept secrets, our new Online Learning System. Launched just a few months ago, the Online Learning System is a robust tool that brings new capabilities to your online education experience with teaching tools that foster more logical, intuitive and active learning opportunities. Here are just a few things that the Online Learning System can do for you:

  • Search all of ISPE's online learning offerings by topic, keyword, or format
  • Progress through lessons at your leisure - save your progress and pick up right where you left off when you come back
  • Customize your learning through the My Learning dashboard
  • Track your learning history
  • Track and print CEUs

The Online Learning System is a whole new way to get the most out of ISPE's online education. Access the system through your ISPE Member login, and learn more about how the Online Learning System can help advance your career.

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ISPE now offers a Guidance Document subscription service! This service offers web-based, multi-user access to ISPE Guidance Documents, allowing you and other registered users in your organization to access the Guides you subscribe to from any computer in the world, 24/7. The Guidance Document subscription service is offered through our partner Techstreet, and can be bundled with other publications from the world’s leading standards publishers to create a one-stop online tool for your auditing, compliance, and regulatory needs.

Learn more about the Guidance Document subscription service, or call Techstreet at +1-800-699-9277 or +1-734-780-8000 to start building your custom subscription.

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What did you think of this month's Gift offerings? Are there topics and resources you'd like to see covered in future gift emails? We want to know! Please send all feedback to

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