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 the pandemic have been combined with FDA knowledge from prior public health crises to...
iSpeak Blog
2020 ISPE Europe Annual Conference
This article covers a regulatory panel discussion at the virtual 2020
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 people’s careers follow their parents, grandparents, siblings, and other relatives’ footsteps. I...
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...