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Why do I go to a conference? Primarily I do this for two reasons. Firstly, for me a conference is still the perfect forum to understand market dynamics via presentations, workshops, interactive discussions and meet and greet opportunities. This brings...

Sustainability as a topic is extremely broad and, in some areas contentious. Even more so when it is applied to the diverse and complex, yet product focused, pharmaceutical industry. The increasing recognition and understanding of the need for patient...

Lower production costs, improve process efficiency, increase production quality and meet regulatory requirements with ISPE Training. ISPE Training Institute: February Auditing Bio Manufacturing Bio Process Validation C&Q GAMP®...

2016 Aseptic Processing Technology Conference 29 February – 1 March 2016 Arlington, VA At the 2016 ISPE Aseptic Processing Technology Conference, Joan Byrne, Vice President, Biologics and Combination Products, Abbvie Quality Assurance, explores...

Robert Dream, Principal, HDR, Inc., explains the benefits of the ISPE Sustainability Handbook and what it can do for your facility. Buy Now

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....

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...

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...

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...

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....

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...

“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...

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...

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...

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...

  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...

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...

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...