The past year has been unprecedented for the manner in which the world’s population has adapted to living with the changes brought about by COVID. The life sciences sector has always been to the fore at unleashing scientific innovation to make life better for humanity, and that creativity went into overdrive as the industry pivoted to meet those challenges.

Featured in this edition of iSpeak Reading Roundup, are the top blog posts from June 2021. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.

COVID-19 has caused disruptions and delays with supply chain all across the world. Single-Use technologies (SUT) play a vital role in manufacturing of pandemic vaccines and have drastically reduced the typical vaccine development and manufacturing production timelines. The pandemic has further increased the sourcing demands for SUT. This non-forecasted demand has led to extended lead times or...

Featured in this edition of the Pharmaceutical Engineering® Online Reading Roundup are suggested summer reading ideas—articles on important topics from recent issues to revisit when you have some down time this summer—or to enjoy for the first time in case you missed them. Learn more about knowledge management implementation, zero carbon, MES, and more.

In the global business environment, advancements in technology and digital platforms are changing how business operations are being carried out. The big data explosion has ensured that business and the digital platform become synonymous to enhance the productivity and efficiency of businesses.1

• 1Roberta S. Russell & Bernard W. Taylor, Operations Management: Creating a Value...

John Clarke works with Pfizer in Dublin, Ireland and is currently the Process Lead on a facility expansion project for conjugate vaccine manufacture. John graduated from University College Cork with a Bachelor of Science in Microbiology and earned a Masters of Engineering Science in Biopharmaceutical Engineering from University College Dublin and has held roles across Quality, Validation, and...

What a year to be agile for collaboration and innovation! Our industry has been driving unprecedented success for patients this year, which is fitting for the 2021 ISPE Annual Meeting & Expo theme, “Agility. Collaboration. Innovation.”

Heating, Ventilation, and Air Conditioning (HVAC) systems are critical systems that can affect the ability of a pharmaceutical facility to meet its objective of providing safe and effective products to patients. In this iSpeak blog post, we talk with leading expert Norman Goldschmidt, President, Genesis AEC, on some HVAC FAQs.

Featured in this edition of iSpeak Reading Roundup, are the top blog posts from May 2021. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.

There are two different sides of confidence which I would like to discuss here: the idea of confidence in the workplace and confidence in oneself. 

The issue of data integrity may appear archaic in a highly connected, digital world. Yet many within the pharmaceutical industry it continues – be it intentional or not – to fall foul of regulators tasked with auditing businesses’ practices. Peter Cusworth at Yokogawa examines an age-old problem, its importance, and why organisations continue to get it wrong.

The wait is over… The 2021 ISPE Annual Meeting & Expo is back and will be held in Boston, Massachusetts, at the Hynes Convention Center and Sheraton hotel from 31 October–3 November. This year’s...

Featured in this edition of the Pharmaceutical Engineering Online Reading Roundup are the most read online articles during May 2021. Learn more about cleanliness classifications for facilities, steam sterilization, GAMP®, and more from what visitors to the PE Online site were reading last month

I am excited to share with you that the first “Face to Face” ISPE Conference since the beginning of COVID-19 is now scheduled to take place in North Bethesda, Maryland, USA, on 1–2 February. The

Thomas Hartman, ISPE’s President & CEO and active ISPE Member for over 20 years, speaks with us on his favorite ISPE memories, his real-world examples on the benefits of ISPE, and why volunteering is so important. Join us as we get to know Thomas a little more.

Dr. Randy Perez retired from the position of Director of Information Governance and Management for Novartis Pharmaceuticals in 2015. During his 32-year tenure at Novartis his responsibilities included a wide range of IT Compliance issues, such as GxP, Sarbanes-Oaxley, and data privacy. He served on several global teams dealing with computer systems compliance issues and authored many of the...

ISPE continues to work with a group of industry associations to assist the European Union (EU) and the European Medicines Agency (EMA) with implementation of revision of Annex 1, Manufacture of Sterile Products....

This virtual ISPE Global Pharmaceutical Regulatory Summit, held on 28 April 2021, brought together eleven regulators from different parts of the world to discuss how their approach to GMP inspections have adapted to the COVID-19 pandemic. Such a large number of regulators at a single forum is unprecedented for ISPE.