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Pfizer Inc. is the 2016 ISPE Facility of the Year Winner for Equipment Innovation for their Portable, Continuous, Modular, and Miniature (PCMM) Collaboration project located in Groton, Connecticut. Pfizer is an industry leader in applying science and...
iSpeak Blog
Regulatory agencies, as well as industry, rely on accurate information to ensure drug quality and patient safety.  If the information associated with a drug product is not accurate, complete, or reliable, a company cannot ensure the safety and efficacy...
iSpeak Blog
As a conference co-Chair you often experience surprises, such as speaker cancellations at the last minute, venue changes, content updates, etc.  Well this time, this situation was driven by Germany’s recent wave of colds and influenza. And, yes, I did...
iSpeak Blog
The Manufacturing and Operational Excellence Track at the 2016 ISPE/FDA/PQRI Quality Manufacturing Conference will help you benchmark your company's practices against those with demonstrated success at improving manufacturing quality and preventing...
iSpeak Blog
Takara Bio Inc. is the 2016 ISPE Facility of the Year Winner for Facility Integration for their Center for Gene and Cell Processing Construction Project located in Kusatsu, Japan. Takara Bio Inc. operates in three core areas: bio-industry, agri-bio,...
iSpeak Blog
We would like to personally invite you to join us at ISPE's first conference focused exclusively on Continuous Manufacturing – an increasingly popular production strategy with numerous benefits, but also many challenges. Our dedicated program committee...
iSpeak Blog
All interfaces have the potential to present data integrity issues, due to their nature: They're often custom (category 5) software components, with a raised level of inherent risk in the absence of a well-planned specification, design, review, and...
iSpeak Blog
Genentech, a member of the Roche Group, is the 2016 ISPE Facility of the Year Award Winner for Process Innovation for their Cell Culture Plant 2 (CCP2) Manufacturing Facility and Return to Service (RTS) project located in Vacaville, CA. Genentech is a...
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Industry Embraces Renewable Energy is featured in the January/February 2016 issue of Pharmaceutical Engineering® Magazine. Electricity use for process manufacturing can account for a substantial portion of a factory’s energy budget, not to mention...
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EU Directive 2001/20/EC worked to simplify and harmonise the administrative provisions governing clinical trials.  It was, and remains, a good attempt but many hold the opinion that the full benefits of the directive haven’t been realized based on...
iSpeak Blog
Ethicon, LLC is this year’s ISPE Facility of the Year Category Award Winner for Sustainability for their San Lorenzo Conservation Strategy project located in San Lorenzo, Puerto Rico. The facility was established in 1988 as a high technology...
iSpeak Blog
It’s time for another edition of the Reading Roundup featuring the top blog posts from February 2016.  Grab your favorite cup of coffee, kick back and catch-up on what the pharmaceutical industry was reading in February. Non-GMP or GMP Washers and...
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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...
iSpeak Blog
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...
iSpeak Blog
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...