How to perform a robust Vaccine Technology Transfer in a challenging era
Operational Technology and Cyber Security must walk hand in hand by Danilo Maruccia […]
Impact of possible removal of the Titanium dioxide from human medicines formulations […]
5 questions (plus, a bonus one) you should be able to answer […]
Technology Transfer has always been a hot topic and can be even more challenging for complex processes/products like biotechnological ones.
In this Covid-19 pandemic era, different companies are facing technology transfer processes as a mandatory way to boost their covid vaccines production and follow patients’ need, shifting a series of contract manufacturers across the world that must inherit their technology and achieve compliance in a really short timing to meet the production goals.
Pharmacovigilance Data: challenges for Pharmaceutical Companies by: Daniela Rota PV Unit Manager […]
GDPR: 3 years later What we learned and what we need to […]
Covid-19 & Pharmaceutical manufacturing: the challenges for production quality, safety and continuity
New Annex 1, among other important points considered, dedicates several comments on the importance and the impact of Critical Utilities, involved at different level either because directly impacting on Contamination Control Strategy (CCS) document, or because potential direct or indirect source of bio-contamination of the final product.
EU MDR 2017-745: New Cybersecurity Requirements for Networked MD producers by Danilo […]