Read, Learn, Innovate: Top Blog Posts from December 2020
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.
Breaking the Document Mindset
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.”
PIC/s Annex 2a ATMP Revisions, Bio-Safety, Rapid Micro Method RMM and Contamination and Cross-Contamination Control Strategy
The 2021 ISPE Aseptic Conference 30th Anniversary will be held on 15 – 17 March offering attendees several unique perspectives and case studies across two separate tracks. For many years, the ISPE Aseptic Conference has been an integral part of my professional career and the most important kick-off event of the year where everyone who deals with aseptic production meets.
Celebrating 30 Years – The 2021 ISPE Aseptic Conference
It is time to celebrate the 30th anniversary of the ISPE Aseptic Conference at the 2021 ISPE Aseptic Conference. Hard to believe, isn’t it?
Current Challenges in Implementing Quality Risk Management
This article was published in the November/December 2016 edition of Pharmaceutical Engineering® magazine. It is one of five articles nominated for the Roger F. Sherwood Article of the Year Award, all which will be posted to iSpeak throughout the week of 5 December.
FDA Commissioner Hahn: Lessons Learned From COVID-19
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 maintain ongoing and safe development and supply of medicines and other medical products.
