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Featured in this edition of iSpeak Reading Roundup, are the top blog posts from December 2020. 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
As we enter the new year, this is the perfect time to make the 2021 ISPE Aseptic Conference part of your personal professional development plans. The virtual conference will allow participation from across the globe with no risk to pandemic exposure. The three-day format with shorter sessions will...
iSpeak Blog
Lou Kennedy, Nephron Pharmaceuticals’ President & CEO and active ISPE Member, was recently honored with a 2020 Business Leader and Public Servant of the Year Award. We spoke with Lou to learn more about her company, the many initiatives she and Nephron are undertaking on behalf of pharma, Nephron’s...
iSpeak Blog
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from November 2020. 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 Life Sciences industries adhere to strict documentation practices to prove quality and compliance. We’re all familiar with the truism “If it isn’t written down, it didn’t happen.”
iSpeak Blog
FDA Commissioner Stephen M. Hahn, MD, spoke about the lessons learned from COVID-19 in a presentation during the ISPE Annual Member Meeting on 5 November at the 2020 ISPE Annual Meeting & Expo. He discussed how the FDA has been responding to the pandemic, including how actions taken in response to...
iSpeak Blog
2020 ISPE Europe Annual Conference This article covers a regulatory panel discussion at the virtual 2020 ISPE Europe Annual Conference on the topic of Distant Assessments on GMP and Inspection Reliance. Driven by digitalization, these assessments help the industry and regulators manage inspection...
iSpeak Blog
We are constantly being influenced and we ourselves are influencers. As children, we hear the quote that “sticks and stones may break my bones, but words will never hurt me.” What people say and even what people do not say, can have a lasting impact. We are first influenced by our families and some...
iSpeak Blog
2020 ISPE Europe Annual Conference At the 2020 ISPE Europe Annual Conference on 16–17 September, which was a virtual conference, three regulatory panel discussions included more than 20 regulators from eight countries and the European Medicines Agency (EMA), Medicines and Healthcare Products...
iSpeak Blog
Article 117 of the EU Medical Device Regulation (MDR), fully applying May 26, 2021, is significantly impacting BioPharma companies. While integral drug-device combination products (such as pre-filled syringes and pre-filled injectors) are regulated as medicinal products in Europe (EU), certain...
iSpeak Blog
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from October 2020. 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
2020 and the COVID-19 pandemic have presented tremendous challenge to the world and the pharmaceutical industry—but from the pandemic has come stepped up development of vaccines and treatments, increased urgency to address supply chain challenges, and forging ahead to develop and expand of cell and...