Monthly Member Gift June 2011 | ISPE

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Make the Most of Your Membership!

Welcome to your free monthly gift from ISPE! This edition marks the one-year anniversary of ISPE's efforts to help you get the most out of your Membership by sending free knowledge, community, and professional resources right to your inbox. We sincerely hope you're enjoying this monthly delivery, and that it inspires you to take advantage of all ISPE has to offer!

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FREE Keynote Recording for Members

Have you been involved in the design and installation, qualification, or maintenance of HVAC systems, and had projects not turn out like originally planned? Don't worry - you're not alone! This month's FREE Member gift, recorded at the 2010 Annual Meeting, gives a regulatory perspective on HVAC cGMP, and it illustrates how a single event can lead to other issues

Titled, HVAC cGMP Trends and Development in bio/Pharmaceutical and Medical Device Facilities - a Regulatory Perspective, this 30-minute presentation by US FDA Office of Regulatory Affairs Inspector Thomas Arista will help you to identify who and which departments should be involved with the risk assessment, understand that even the best risk assessment can produce less than acceptable outcomes, and learn how to avoid these situations. Don't waste money on costly mistakes - watch the presentation now!

FREE webinar: HVAC cGMP Trends and Development in bio/Pharmaceutical and Medical Device Facilities - a Regulatory Perspective
Free to Members through 31 July 2011

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KNOWLEDGE

This month, get a special preview of the soon-to-be released ISPE Baseline Guide on Sterile-Product Manufacturing Facilities. This second edition of the Guide reflects ISPE’s current thinking related to engineering of new (or existing) aseptic manufacturing facilities. It takes into account updated regulatory GMPs and guidance from both the US and Europe, and a new ISO Standard. The Guide has also been subject to extensive review by both industry and regulatory representatives. The  document focuses on facility engineering issues, covering how to provide cost effective facilities which make best use of available modern technologies which ensure products of the highest quality are consistently manufactured. This Guide also covers facilities for aseptic processing and terminal sterilization of APIs (from either conventional chemistry or biopharmaceutical processing) and formulated products. Read the first chapter now ( 540 KB) !

The anticipated release date for the ISPE Baseline Guide on Sterile-Product Manufacturing Facilities is September 2011. 

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COMMUNITY

ISPE’s HVAC Community of Practice (HVAC COP) was formed in 2005 by a group of HVAC experts who had worked on ISPE Baseline® Guides. The HVAC COP provides critical tools and services to ISPE membership, such as the HVAC COP Good Practice Guide, a three-day HVAC Training Course, and numerous Pharmaceutical Engineering Magazine articles. The HVAC COP is actively involved in representing ISPE and the pharmaceutical industry in international forums like ISO, WHO, IEST, and ASHRAE. Learn more about ISPE's HVAC COP .
 

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STRATEGIC PLANNING UPDATE

We have great 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 . The Board of Directors would like to invite you to learn more about the new plan. Please consider attending one of two free interactive information and discussion sessions coming up soon.

 
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PROFESSION

ISPE’s new strategic plan focuses on increasing professional development.  In the coming months and years, Members will see increased opportunities for life-long learning and new tools for mapping your career. It’s going to be exciting!

Meanwhile, have you considered the CPIP credential in your professional development plans?  Obtaining the CPIP certification tells employers, customers and colleagues that you have demonstrated competencies essential for excellence in the pharmaceutical industry. It sets you apart and can be an important part of guiding your career journey.

Find out more about the CPIP credential, or email Michael Phelan, Director of Professional Certification with specific questions.

You may be more ready than you thought to take and pass the CPIP examination. You can find out how by trying the CPIP Practice Exam.

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DID YOU KNOW?

Regulators make great ISPE Members!  Regulators play a vital role in the life of ISPE. As Members they take an active role in the exchange of expert knowledge and practical experiences. Together with their agencies, many regulators help ISPE articulate new information and develop good practices that ultimately benefit all ISPE Members and the industry as a whole.

Complimentary membership is available to all regulators worldwide. For Regulatory Authority/Government Agency representatives not able to accept the complimentary membership, a rate of $65/€65 is offered. Encourage regulators you know to learn more and to join ISPE today!

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TELL US WHAT YOU THINK

Has receiving these emails during the past year helped you to make the most of your ISPE Membership? Are there topics and resources you'd like to see covered in future gift emails? We want to know! Please send all feedback to kkos@ispe.org.


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Last Update: 16 September 2011

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