Monthly Member Gift April 2011

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Make the Most of Your Membership!

Your April gift from ISPE is here! We know you can't wait to receive this month's FREE Knowledge, Community and Professional resources, so read on to see what goodies ISPE has in store for you this month! Enjoy!

Free to Members Icon

FREE Keynote Recording for Members

21 CFR Part 11 is a perennial "hot topic," because it affects every aspect of computerized systems in the pharmaceutical industry. This month's FREE Member gift, from the 2011 Tampa Conference, features acknowledged computer systems validation and compliance expert and FDA CFR 21 Part 11 panel member Sion Wyn discussing current inspection findings, expectations for GMP and quality systems, the quality of the supply chain by adequate qualification of vendors and contract manufacturers, expectations of management, and CDERs Part 11 inspectional assignments.

This 50-minute presentation will help you understand the need for record integrity and controls, give you practical tools to help understand GAMP Guidance, and help you learn how to prepare for Part 11 inspection. View the webinar now!

FREE Webinar for Members: 21 CFR Part 11 - an Industry Perspective
FREE through 31 May 2011

Knowledge Icon


The global pharmaceutical industry and regulators are responding to the challenge of significantly improving the way drug development and manufacturing is managed. New concepts are being developed and applied, including science-based risk management approaches, a focus on product and process understanding, and the application of Quality by Design concepts.

Our Knowledge resource for you this month is a special Members-only preview of Chapter 1 of the upcoming ISPE Guide: A Science- and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment. This Guide provides direction to industry on the implementation of a science- and risk-based approach for demonstrating that pharmaceutical and biopharmaceutical facilities, systems, equipment, and associated automation are fit for intended use.

In this preview, you'll learn the background, scope, and purpose and objectives of the Guide. You'll also read about the key concepts of the Guide, along with the corresponding benefits companies that apply the Guide's concepts can expect to see.
This Guide provides direction to industry on the implementation of a science- and risk-based approach for demonstrating that pharmaceutical and biopharmaceutical facilities, systems, equipment, and associated automation are fit for intended use. Don't miss out - read Chapter 1 now ( 447 KB)!

Community Icon


The Active Pharmaceutical Ingredients Community of Practice (API COP) has about 2,300 members representing the various disciplines associated with active pharmaceutical ingredients such as Manufacturing, Process R&D, Quality Control/Quality Assurance, and Regulatory Affairs. The API COP provides a unique global forum for industry professionals to work in partnership to drive innovation and share expertise in process technologies and quality systems for the manufacture of APIs. Membership of the API COP includes pharmaceutical manufacturers, equipment suppliers, engineering service providers, academics, and regulators.

The API COP plans to publicize and promote an Innovation in Process Technology Roadmap guidance document as part of ISPE’s Science and Technology Initiative. This process technology roadmap will be available on the API COP Web site in a downloadable format free to ISPE members. The document will identify and discuss issues, barriers, and needs related to process innovation.

To learn more and begin participating in this exciting COP, please visit and click on “Join a COP.” Then check the box for the API COP and click "Join."



The ISPE Board of Directors announced in March that the Society will be creating a new strategic plan between now and June. You can learn more about the entire project by visiting . On this page, you'll find everything you need to know about the background of the project, the volunteers who are leading it, and the reasons the Board has decided to create a new plan at this time. You’ll also be able to access a webinar led by Board Chair Andre Walker and consultant Ann Atkinson explaining this and giving general information about managing change of this nature. As time passes and the process evolves, you’ll always be able to check out the progress of ISPE’s strategic planning project by returning to this page .

Expected milestones:

  • March/April 2011 – Stakeholder input period. THANKS to everyone who provided their ideas!
  • May 2011 – Development and review of draft plan.
  • June 2011 – Stakeholder representative meeting in Washington; Board finalizes and votes on the macro-plan for 2012-2016; online stakeholder sessions to review the new plan (watch this space or check the web page above for dates/times to be announced in May).
  • July/August 2011 – Detailed planning for 2012
  • September 2011 – Stakeholder meetings in Brussels; Board finalizes and votes on detailed Business Plan for 2012
Profession Icon


The Certified Pharmaceutical Industry Professional™ (CPIP™) credential can be a terrific way to advance your career. Since certification is awarded by the ISPE Professional Certification Commission (PCC), an independent governing board, the CPIP credential demonstrates an objective standard of industry knowledge that can be trusted by colleagues, hiring managers, supervisors, and others in the pharmaceutical industry around the globe.

Recently, the PCC has taken steps to simplify the certification process to help even more people earn their CPIP credential. For starters, the Eligibility application process forms have been simplified and made to be more user-friendly. Additionally, the PCC has created a new webinar to guide candidates to successfully document their experience in order to achieve eligibility.

For more information on CPIP certification, including eligibility requirements, practice exams, and study group information, visit

Did You Know Icon


GAMP® is celebrating its 20th Anniversary in 2011. To mark the occasion, ISPE will be hosting its first-ever two-day conference focused entirely on GAMP 12-13 September 2011 in New Brunswick, New Jersey. Why is this important? There are a lot of imitators, but ISPE is GAMP. The Society has been issuing GAMP guidance documents and providing education since the beginning. We own the GAMP name, the trademark, and we lead everyone in providing real-world answers and state-of-the-art approaches to managing risk-based commissioning and qualification and computerized systems validation. The GAMP COP leaders have put a special program in place for this event and – in addition – GAMP participants are invited to attend the ISPE New Jersey Technology Showcase free of charge. This includes access to additional networking, a special Keynote Speaker, and delicious food. Thanks to all of ISPE’s GAMP volunteers over the years and to the New Jersey Chapter for making this special event possible!

Visit the event website for more information on the New Jersey GAMP event.

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