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...
