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In September 2021, a panel of regulators representing ANSM (France), ANVISA (Brazil), FDA (US), and the WHO participated in a webinar to discuss opportunities for drug shortage prevention. The discussion was facilitated by industry leaders while industry insights were obtained through polling of...
iSpeak Blog
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...
iSpeak Blog
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.
iSpeak Blog
The ISPE Aseptic Conference is in its 31st year. This year like many others, we have a long list of enigmatic speakers discussing topics that matter to your everyday business. But unlike in years past, we have more to celebrate. After a long period with us pouring our energy into producing the...
iSpeak Blog
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 published and is the culmination of a year-long effort of a multi-national, cross-functional team of industry experts....
iSpeak Blog
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 accomplishments in facility design, construction, and operation, new applications of...
iSpeak Blog
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 20 years, the alignment of the people, processes, and tools and the data they collectively manage produces...
iSpeak Blog
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.
iSpeak Blog
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...
iSpeak Blog
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...
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