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Innovation - Integration - Integrity The 2016 Europe Annual Conference will kick-off on 7 March 2016 in Frankfurt, Germany.  This year’s conference will focus on integrated technology and quality and compliance strategies for effective operations....
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As pharmaceutical manufacturers, we’re used to change. Advancing technology, updated systems, and new research are constantly forcing us to learn and adapt. But, being used to this kind of constant change doesn’t necessarily make it easy. A qualified...
iSpeak Blog
Grab your favorite cup of coffee, kick back and catch-up on the top blog posts from December 2015: GAMP: Administrators for Instruments – Your Administrator Part 2 Learn about the the potential issues when your administrator is also a user and how to...
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The Data Quality Equation Regulatory agencies around the globe are focused on assuring patient safety and product quality; if we focus on the latter, product quality, many regulations and guidance identify the elementary expectations to achieve it....
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The 2015 International Student Poster Competition was held at the ISPE Annual Meeting in Philadelphia, Pennsylvania, USA. The competition had a great turnout with a lot of exceptional research presented. This year, the undergraduate winner was Neeraja...
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“It’s a great time to be a regulator!” kicked off the first-ever Global Regulatory Town Hall at the ISPE 2015 Annual Meeting.  The attendees received the chance to hear directly from 10 FDA and international regulators in a question-and-answer style...
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At the Annual Meeting Member Breakfast and Awards Ceremony, former ISPE Chair of the Board Andy Skibo officially passed on the gavel to incoming Chair Joseph Famulare. Famulare spoke on what’s ahead for ISPE and the pharmaceutical industry. ISPE...
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ISPE’s Facility of the Year Awards (FOYA) program recognizes projects that exemplify global leadership by showcasing innovative engineering, cutting-edge new technology or advanced applications of existing technology. ISPE is now accepting applications...
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October is here, and updates to the European Commission’s Annex 15 Qualification and Validation are officially in effect. The update, which was drafted in March 2015, incorporates lifecycle validation requirements similar to those in FDA’s 2011 Guidance...
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  Defined, sampling is the process of taking a small but representative portion of a much larger stream, where the sample collected accurately represents the content of the larger stream. Effective sampling is a very important part of process validation...
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Preventing cross-contamination is a significant challenge that must be addressed for pharmaceutical manufacturers during manufacturing, packaging and inventory management operations to ensure the quality of supply to patients. The changing industry...
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There have been situations where people struggled to separate integrity and quality.  A search of the internet only reinforced the confusion; so let’s compare and contrast the terms. Data Integrity-Defined Wikipedia defines data integrity as “maintaining...
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ISPE serves as the catalyst for solutions that influence global public health and ensure the safety of the world's supply of medicines through its many training resources. In order for ISPE to maintain its position as the go-to resource by manufacturing...
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ISPE President and CEO John Bournas welcomed attendees and thanked both the companies participating in Wave 1 of the ISPE Quality Metrics Pilot Program for their expertise and enthusiasm and the ISPE Quality Metrics Task Force for their hard work. “It...
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July/August 2014, Volume 34, Number 4 Chemical and Media-Free Pretreatment for Biopharma RO – Electrolysis for Scale Precipitation and UV Dechlorination by Nissan Cohen and Shlomo Sackstein This article identifies the issues plaguing water systems with...