The uncertainty that comes with the introduction of a new idea has affected society for centuries. We all grew up hearing about how sailors of old feared sailing off the edge of the world before we accepted that the Earth was indeed round. Inventors are always ridiculed by naysayers until their ideas are adopted and become common place. It’s safe to say that most of us approach new ideas with...

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

The ISPE Aseptic Conference is in its 31^st year. This year like many others, we have a long list of enigmatic speakers discussing topics that matter to your everyday business. But unlike...

Late last month, ISPE published the 2nd Edition of the ISPE Good Practice Guide: Good Engineering Practice. This revision comes a decade and a half after the original guide was...

Featured in this edition of the Pharmaceutical Engineering® Online Reading Roundup are popular articles that visitors to the site were reading during October. Revisit articles on cleanliness classifications, steam sterilization, pharma water systems, and more.

ISPE’s Facility of the Year Awards (FOYA) celebrates cutting-edge engineering, new technology, and unique collaborations. It provides a platform for the pharmaceutical science and manufacturing industry to showcase...

Over the past twenty years, an evolution of pharmaceutical development has resulted in new approaches to ensuring product quality and patient safety. The science and risk-based concepts outlined in ICH Q8-Q12 encourage a more holistic approach to the product control strategy. Under this paradigm, product quality should not be ensured by the quality specification, rather it should be confirmed....

Since the FDA issued final guidance on Data Integrity in 2018, the challenges have been many. The growth in observations has been substantial. With IT transforming dramatically over the last...

The final session of the 2021 ISPE Annual Meeting & Expo was the Global Regulatory Town Hall. It brought together regulators from around the world to provide insights about current issues including harmonization and convergence. This year’s panel session was heavily flavored by inputs about lessons learned by regulators during the pandemic, and what may change (or not) after pandemic.

The Membership and Awards Breakfast at the 2021 ISPE Annual Meeting & Expo on 2 November saw the traditional passing of the gavel in person for the first time in two years as Jörg...

The theme of the 2021 Annual Meeting & Expo is agility, collaboration, and innovation, and these were demonstrated from a number of perspectives in the keynote presentations during the...

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

Raymond G. Perelman Center for Cellular and Molecular Therapeutics is one of the 2021 Facility of the Year Awards Winner for the 2021 Facility of the Year Honorable Mention...

Erich Bozenhardt is a BioProcess SME and internationally recognized authority in the domains of cell and gene therapy and bioprocessing. He is a Lead Process Engineer in Regenerative Medicine Operations at United Therapeutics Corporation. During his career, Erich has led the process activities for several biopharmaceutical projects, provided internal and external project leadership, is a...

Locus Biosciences is one of the 2021 Facility of the Year Awards Winner for the 2021 Facility of the Year Honorable Mention Award for their...

There are many benefits to networking. In addition to strengthening business connections and meeting new people, it can help you discover new ideas and gain a fresh perspective on topics in the life sciences and pharmaceutical industries. It can help you advance your career and learn about new opportunities. Done properly, networking can introduce you to people that will become mentors and...

ISPE’s Pharma 4.0™ initiative provides guidance, aligned with the regulatory requirements specific to the pharmaceutical industry, to accelerate Pharma 4.0™ transformations. Also known as the Smart Factory, the objective of Pharma 4.0 is to enable organizations involved in the product lifecycle to leverage the full potential of digitalization to provide faster innovations for the benefit of...

One of the most significant changes to the pharmaceutical industry in the last decade has been the increased speed in developing new therapies. A striking example of this is the rapid rollout of the COVID-19 vaccines. What usually took 10-15 years was researched, developed, and put into production in less than a year after scientists successfully revealed the virus's genetic code in January of...