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ISPE has just released a new process validation discussion paper:  Determining the Number of Process Performance Qualification Batches Using Statistical Tools. The purpose of this paper is to present four statistical tools that may be applied to...
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As we celebrate our 25th year of the Aseptic Processing Technology Conference, we’re excited to bring you world-class education on the most relevant topics surrounding aseptic processing.  Two education tracks will make-up the backbone of the...
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Janssen Vaccines AG located in Bern, Switzerland is this year’s Facility of the Year Awards (FOYA) winner for Project Execution for their “Fast Track Refurbishment for Ebola Vaccine Production” program. Janssen Vaccines AG, one of Janssen...
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The ISPE Europe Annual Conference is right around on the corner on 7-9 March 2016 in Frankfurt, Germany.  I have participated in and attended a lot of ISPE conferences in my career, and I feel the Europe Annual Conference education program this year is...
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As a student member of ISPE and a Young Professional engaged in the pharmaceutical industry, I looked up to the ISPE International Board of Directors.  I expected guidance, direction, education and strong leadership from this perceived “untouchable”...
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Revolutionize Your Operations with Tools & Strategies at Continuous Manufacturing Conference We are pleased to invite you to ISPE's inaugural Continuous Manufacturing Conference! Join us from 20 – 21 April in Baltimore, Maryland for a comprehensive...
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The ISPE Drug Shortages Introductory Webinar The prevention of drug shortages is critical to public health. For years, drug shortages have been a worldwide problem, and ISPE is committed to finding solutions and educating industry professionals about...
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by Marc Schmidt, Business Development Manager, Pharma, for AAF International, Lothar Gail, Senior Contamination Consultant and Hugo Hemel, MSc, EMEA Marketing Manager for air filter manufacturer AAF International This article is featured in the...
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ISPE Board Chairman Joseph Famulare (Vice President, Global Quality Compliance and External Collaboration Genentech/Roche, Pharma Technical Operations) appeared on NPR’s The Diane Rehm Show Monday to talk about Drug Shortages. Along with three other...
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ISPE Announces the 2016 Facility of the Year Awards Winners ISPE's Facility of the Year Awards honor the top pharmaceutical facilities for displaying innovation and creativity in manufacturing facilities serving the regulated healthcare industry....
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Thought-Provoking Sessions You Don't Want to Miss at the Aseptic Processing Technology Conference! Keynote Sessions: Newly Confirmed Speaker: Andrew Hopkins – Tuesday, 1 March Aseptic Processing: A European Regulator's Perspective Learn from Andrew...
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It's time for another edition of the Reading Roundup featuring the top blog posts from January 2016.  Grab your favorite cup of coffee, kick back and catch-up on what the pharmaceutical industry was reading in January. Air Filtration Challenges & Answers...
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High-speed roll-up doors, operated by sensors or push buttons, have become very practical, and where appropriate, a standard solution for openings that are required to accommodate the movement of materials, equipment, and even personnel.  The virtually...