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ISPE’s official blog, iSpeak accepts contributions from our Members and professionals in the pharma industry.  

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iSpeak Blog

In recent years pharmaceutical manufacturers have responded to increased demands for speed to market, rapid drug development, and increased manufacturing capacities with innovative approaches to adapt to quickly shifting global needs. The design and construction of pharmaceutical facilities has evolved as companies identify ways to prepare new and existing facilities for future needs and...

iSpeak Blog

During the 2023 ISPE Membership Meeting and Awards Lunch, Michael Rutherford, the outgoing Chair of the 2022-2023 ISPE International Board of Directors, officially handed over the gavel to Scott Billman. As the new Chair for the 2023-2024 term, Scott Billman, Vice President, Engineering, Pharmaceutical Services, Thermo Fisher Scientific, will lead the board. Rutherford expressed his gratitude...

iSpeak Blog

A fireside chat featuring Robert M. Califf, MD, FDA’s 25th Commissioner of Food and Drugs, and Thomas B. Hartman, President and CEO of ISPE kicked off the 2023 ISPE Annual Meeting & Expo. The following is a brief summary of the session. Look for complete coverage of the interview in an upcoming issue of Pharmaceutical Engineering® magazine.

iSpeak Blog

Through the ISPE Foundation Diversity Internship Program, junior undergraduate and graduate-level students are afforded an opportunity to immerse themselves in a summer of groundbreaking engineering projects at some of the most cutting-edge facilities. This experience not only fosters the development of invaluable technical skills, but also serves as a first chance for students to establish a...

iSpeak Blog

The countdown has begun, and the anticipation is evident as we gear up for the highly anticipated 2023 ISPE Annual Meeting & Expo. As we look back at the successful conferences over the past years, this event promises to be nothing short of extraordinary, especially for students and Emerging Leaders.

iSpeak Blog

Continued Process Verification (CPV) was introduced roughly 12 years ago by the FDA as a third stage in the guidance on the process validation life cycle. In addition to being a mandatory requirement for the pharmaceutical industry, CPV can also provide valuable information to improve the quality and consistency of products. There may be limited data available when a process is designed and...

iSpeak Blog

At ISPE, our commitment to advancing the pharmaceutical industry has always revolved around delivering gold-standard Guidance Documents — a trusted source of information that’s been a helping hand for professionals like you to rely on when forging new paths and exploring uncharted territory . In the ever-evolving landscape of pharmaceutical and scientific advancements, we understand that how...

iSpeak Blog

Few industries have as deep a footprint in California, USA as life sciences. The sector is home to nearly 14,000 businesses that employ more than a million people at an average wage of more than $162,000 – Californians employed in life sciences earn a staggering $54.6 billion a year. And despite uncertainties in the US economy and massive layoffs in the high-tech sector, California life...

iSpeak Blog

For several years, ISPE has steadfastly organized hands-on training sessions to enrich classroom learning. Despite the challenges posed by the pandemic, we have successfully developed a program that integrates practical, experiential learning, leveraging ISPE's comprehensive training materials. We are thrilled to announce our partnership with the European Aseptic and Sterile Environment (EASE)...

iSpeak Blog

PIC/s Annex 1, and the WHO Annex 2 for the manufacturing of sterile products took effect on 25 August 2023, and the time to attend the 2023 ISPE Pharma 4.0™ and Annex 1 Conference couldn’t be better. The Equipment Innovation and Annex 1 Implementation Track Co-leads Richard Denk and Matthew Gorton and the Emerging Leader Co-lead Pol Bonet invite you to join them for this exciting event in...

iSpeak Blog

The pharmaceutical industry is constantly evolving, placing a significant emphasis on emerging technologies that facilitate quicker access of medications for patients globally. This unceasing drive for innovation and improvement has led the industry to embrace cutting-edge technologies like data analytics, machine learning, and artificial intelligence. These technologies are not just trends;...