Covid Vaccine Technology Transfer: 5 reasons, risks, good practices

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.

GDPR: 3 years later What we learned and what we need to know about (whitepaper)

GDPR: 3 years later What we learned and what we need to know about by PQE Group The General Data Protection Regulation (GDPR) of the European Union entered into force on 25 May 2018. It has been three years since the GDPR came into force, and during that time, we have seen more published EU-wide guidelines […]

Critical Utilities GMP Compliance and new Annex 1

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.

New EU GMP Annex 1: Implications for QRM application

New EU GMP Annex 1 – Implications for QRM application by Alessio Rosati Sterility Assurance Executive Consultant – PQE Group The issues exposed in this article will be discussed in “Risk Based approach to Qualification Activities” free Webinar by PQE, on April 20th@ 10 a.m. CET. Register now to secure your presence. Introduction After a […]

Windows 7 to 10 migration strategy

How to deal with Windows end-of-life

We consider the potential risks for Pharma and MD companies keeping their systems running on obsolete Windows versions and a good strategy to get up to date.

Cybersecurity for Medical Devices risks and vulnerabilities

Why MD Cybersecurity is so important

Why MD Cybersecurity is so important by Danilo Maruccia, Executive Consultant & Business Partner – PQE Group Is Cybersecurity important for Medical Devices? The answer is absolutely yes. But let’s move a bit backwards, to understand the reason why nowadays Cybersecurity has become a main concern for all Medical Devices producers.