Monthly Member Gift November/December 2011

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Make the Most of Your Membership!

Welcome to your free monthly gift from ISPE! Don't let a single ISPE Membership benefit go to waste - enjoy these FREE knowledge, community, and professional resources, available only to ISPE Members!

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FREE Online Learning Course

This month's Member Gift is something that will truly be of value to every ISPE Member. Quality is a persistent concern for the pharmaceutical industry, and quality systems education is a must for every medical device and pharmaceutical company in the world. This month's FREE online learning course, "Quality Systems: Risk Management and Quality Management Systems," is designed to provide broad fundamental industry knowledge through a customized learning experience. It is part of a series developed and reviewed by expert instructors and international regulatory advisors for individuals who want to acquire the Certified Pharmaceutical Industry Professional™ (CPIP™) credential or those interested in diversifying their knowledge from product development through manufacturing. Don't miss this limited-time chance to take this online course, which usually sells for US$149, absolutely FREE of charge. Happy Holidays!

FREE Online Learning Course: "Quality Systems: Risk Management and Quality Management Systems"
FREE to Members through 31 January 2012

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Among the Guidance Documents that debuted at Annual Meeting were the first two in the new PQLI® Guide Document series. These two new Guides comprise the first and second volumes of a planned series of PQLI Guides, which collectively address product and process development through a Quality by Design approach covering the entire product lifecycle. The series 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. For this month's Knowledge resource, we're giving you a FREE preview of both of these Guides!

The first Guide in the series, Part 1 – Product Realization using QbD, Concepts, and Principles, is focused on the topics of criticality, design space, and control strategy. Part 1 addresses product and process development, transfer to, and establishment of, commercial manufacture using science- and risk-based approaches. It also includes an introduction to, and overview of, the Guide sections.

The second Guide, Part 2 – Product Realizations using QbD, Illustrative Example, presents a small molecule case study providing application of the approaches to product and process understanding using quality risk management. Part 2 also examines many case studies in the public domain using ICH guidelines Q8 (R2), Q9, Q10, and other relevant ICH guidelines.

Download your Part 1 preview ( 254 KB) and Part 2 preview ( 493 KB) now! Both documents will be available through 31 January 2012.

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For our Community resource this month, we're highlighting the group responsible for our Knowledge resource. Product Quality Lifecycle Implementation® (PQLI®) is ISPE’s Global Industry Initiative for a practical approach to implementation of International Conference on Harmonization (ICH) guidances Q8 (R2), Pharmaceutical Development, Q9, Quality Risk Management and Q10, Pharmaceutical Quality System, as well as the more recently initiated topic, Q11, Development and Manufacture of Drug Substances. ISPE began the PQLI initiative as a way to help the industry find global solutions to the challenges of implementing ICH.

ISPE’s PQLI initiative is led by a core group of very experienced industry leaders who lend their expertise to assist the industry more effectively implement ICH. The community also consists of dozens of leaders from many different disciplines of the industry working together on task teams to produce PQLI educational conferences and the newly released Guide Series. 

Please visit the PQLI Resources page to learn more and become engaged in the PQLI Community.  

Profession Icon


Last month, we told you about the changes recently implemented for the Certified Pharmaceutical Industry Professional™ (CPIP™). These changes were designed to offer:

  • Streamlined eligibility requirements
  • Earlier access for Young Professionals
  • Greater focus on pharmaceutical-specific knowledge and skills

These changes have made CPIP more accessible than ever, as evidenced by our two newest CPIPs. Jennifer Lauria Clark and Amy Lineberry, both of whom are Members of the Young Professionals Committee, took and passed the CPIP in early November, becoming two of the youngest CPIPs ever!

Here's what new CPIP Amy Lineberry had to say about her experience:

"I was excited to learn just before the Annual Meeting in Dallas, TX I was one of the newest and youngest CPIPs. I encourage all YPs to strive to achieve CPIP status not just for your company but for yourself. I learned a lot of new things and refreshed my memory on others in the study group we had in the CASA Chapter. Being a CPIP at the Annual Meeting has already opened many doors for me personally and professionally."

Want to see if you're ready to become a CPIP and start setting yourself apart in the industry? Take our Practice Exam to test your knowledge and skills.

Did You Know Icon


ISPE’s Refer a Friend program is a great way to share the value of ISPE membership with colleagues and earn a little something extra for yourself. The program is simple – for every prospect you refer who becomes an ISPE Member, you’ll earn a free month of membership for yourself, applicable to your next renewal. Plus, you’ll likely earn the added bonus of your colleagues’ gratitude once they see how many benefits they’ll receive with their membership.

You already know that it pays to be an ISPE Member; Refer a Friend, and it will literally pay to share your membership benefits with your industry colleagues! For more information on the Refer a Friend program, visit the Membership Referral Program page on the ISPE website.

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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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