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University of Strathclyde CMAC is one of three companies recognized as a 2016 ISPE Facility of the Year (FOYA) Honorable Mention Winner for their Technology and Innovation Centre (TIC) Project in Glasgow, Scotland. The TIC is a nine-story collaborative...
iSpeak Blog
Continuous manufacturing is one of the most talked-about pharma trends of 2016. Don't fall behind! Prepare to transform your operations by hearing from renowned global experts who will focus on both small and large molecules at ISPE's upcoming...
iSpeak Blog
The new EU Regulation No. 536/2014 was introduced on 16 April 2014 and is expected to be implemented in Europe by October 2018 at the latest.  In addition to significant changes related to the application process, the Regulation contains rules for...
iSpeak Blog
A GAMP® Approach to Data Integrity, Electronic Records and Signatures, and Operation of GxP Computerized Systems (T50) - New Data Integrity Process Course! Gain tools and techniques to implement proper controls for data to ensure the integrity and...
iSpeak Blog
The global pharmaceutical industry has been involved in a period of transformational change over approximately the last decade, moving from traditional product development methods and Pharmaceutical Quality Systems (PQS) towards holistic and...
iSpeak Blog
What is Granulation: Granulation is the process of joining multiple particles or grains together, typically using a binding agent although mechanical force has been used to bond the particle together as well. This brief will provide the reader with a...
iSpeak Blog
Managing a new project can be daunting – especially when the project is a creating a manufacturing facility in the highly regulated and evolving pharmaceutical industry. Throughout the facility project lifecycle, managers must consider hefty regulatory...
iSpeak Blog
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...
iSpeak Blog
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...