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.
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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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