Introduction and Update on ISPE's New Baseline Guide: Risk-MaPP
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The focus is quality rather than facilities in this introduction to ISPE’s new Risk-MaPP Baseline® Guide, and its application to pharmaceutical compounds. Review the global regulations that created the need for a guideline that outlines a risk-based approach to determine if dedicated facilities are necessary for processing hazardous compounds.
To view the video presention, please click on the following link
View the Introduction and update on ISPE's New Baseline Guide: Risk-MaPP
Posted by ISPE - ENGINEERING PHARMACEUTICAL INNOVATION at 9:11 AM |
14 Nov 2007Introduction on GAMP5
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Good Automated Manufacturing Practice (GAMP) has always been at the forefront of Delivering Today, Transforming Tomorrow. The next version of the GAMP Guide for Validation of Automated Systems (GAMP5) introduces important tools to ensure that ISPE’s computer validation guidance reflects current industry and regulatory thinking regarding the incorporation of science-based risk management principles into the efforts of validating computer applications and qualifying regulated equipment.
This emphasis on well-understood processes and potential risk to patient safety aligns with initiatives such as FDA’s cGMPs for the 21st Century and ICH Q8, Q9, and Q10. Within this scope, leveraging the work of suppliers is also a key factor.
Posted by ISPE - ENGINEERING PHARMACEUTICAL INNOVATION at 8:52 AM | MAKE A COMMENT
21 Sep 2007The Certified Pharmaceutical Industry Professional (CPIP)
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The pharmaceutical industry is undergoing dramatic change! CPIPs are managing this change and driving innovation. Interested in becoming globally recognized as a CPIP? This informational session will acquaint you with the competency-based credential. Explore our site www.ispe-pcc.org to see the competency standard requirements and how the credential can benefit you and the pharmaceutical industry.
Posted by ISPE-PCC, International Society for Pharmaceutical Engineering Professional Certification Commission.
Posted by ISPE - ENGINEERING PHARMACEUTICAL INNOVATION at 8:20 AM | MAKE A COMMENT
31 Aug 2007ISPE Introduction
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ISPE is the world's largest not-for-profit society serving pharmaceutical manufacturing professionals. As a member of ISPE you join experts around the globe in sharpening your skills, building a career, defining best practices and interacting with regulators. Explore our site to see how we can benefit you at www.ispe.org.
Posted by ISPE - ENGINEERING PHARMACEUTICAL INNOVATION at 10:46 AM | MAKE A COMMENT
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Nov 2007 Sep 2007 Aug 2007What Our Members Say
Janice T. Abel, Director
Pharmaceutical Business Invensys
The networking opportunities are invaluable. ISPE is an organization that always delivers benefits no matter what stage of your career you are in. ISPE membership is especially rewarding because of the wonderful staff and volunteers. Pharmaceutical professionals cannot go wrong becoming a Member of ISPE.
Paul Lammers, Engineering Sr. Project Manager
Amgen Inc.
I think ISPE's most important accomplishment is yet to come. I am a member of the Certification Commission and the work being done to integrate industry disciplines and bodies of knowledge will make a difference in how we pull the great minds of our industry together to enhance technology.
Melody A. Spradlin, Senior Manager
Genentech, Inc., USA
Since joining ISPE just two years ago, my professional life has become much more fulfilling. I have made numerous business contacts because of the great networking opportunities. ISPE has kept me in touch with the latest in global regulatory affairs and I’m learning something new everyday from the Baseline® Guides. As a consultant, this has allowed me to provide my clients with the most up-to-date and relevant information available.
Gopal Nair, CEO
GRASP Enterprise, India
I not only ask my people to become Members, but also ask them to get involved with ISPE groups, like those working on the details of ISPE's technical guides and publications. Just being a Member is not good enough. You can only learn by getting involved.
Ulrich Rudow, V.P.
Worldwide Engineering & Real Estate Johnson & Johnson, USA
I think ISPE can be the leader in what we all are trying to accomplish in the pharmaceutical industry. One thing ISPE is working toward is to bring technical resources to its Members for innovation and modernization, and a status parallel to other industries.
Joseph Famulare
Director, DMPQ, OC for the FDA, USA
The best thing about ISPE, in my eyes, is that it evolved from being an inner-industry type of organization to a global organization that has regulators, academia and professors involved. The success of ISPE hinges on the group dynamics that the Society has created, this intercontinental multicultural platform of professionals, which helps all of us best respond to industry changes and prepare for the future.
Udo Vetter, Managing Director
Uv-Cap GmbH & Co KG, Germany