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iSpeak Blog
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...
iSpeak Blog
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.
iSpeak Blog
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...
iSpeak Blog
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...
iSpeak Blog
I’m from the past, but to some degree, we all are. A number of years ago, I received my Bachelor’s degree in mechanical engineering and a desire to make the world a better place. I joined the pharmaceutical industry with that goal in mind. 30 years later, I have that same desire, but the industry...
iSpeak Blog
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...
iSpeak Blog
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...
iSpeak Blog
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.”
iSpeak Blog
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,...
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.
iSpeak Blog
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.
iSpeak Blog
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,...
iSpeak Blog
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 conference theme, ‘Agility. Collaboration. Innovation.’, truly represents how our industry has responded...
iSpeak Blog
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 28–29 September. The 2021 ISPE Facilities of the Future Conference will be an in-person, live event full of topics of...
iSpeak Blog
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.
iSpeak Blog
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...
iSpeak Blog
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. Annex 1 is a key document in "The rules governing medicinal products in the European...