Dave Rushton
Founder
of Paradigm Shift Consulting Limited.
Dave Rushton is Founder of Paradigm Shift Consulting Limited, a Good Distribution Practice Consultancy.
The EU MDR and ISO 13485: Are you compliant?
ISO 13485 and your Quality Management System The European Union Medical Device Regulation (EU MDR) is a new set of rules that came into force on May 26, 2021, replacing the previous Medical Device Directive (MDD) and Active Implantable Medical Device Directive...
Outsourced Activities: How to Manage them
Your Outsourced Third-Party Services and Providers Outsourcing is a common practice in the pharmaceutical industry, where companies may delegate some of their activities to third-party service providers. These activities may include transport, storage, cleaning,...
Why Management Reviews are Important
Management Reviews are important in Pharmacovigilance One of the key elements of a robust pharmacovigilance system is the Management Review, which is a periodic and systematic evaluation of the performance, adequacy and effectiveness of the system and its quality...
CEIV Pharma IATA
Global Air Transportation Industry We’ve all heard of the European Commission for GDP, the MHRA Green Guide and the Human Medicines Regulations 2012 but who is regulating the expansive Global Air Transportation Industry? Have you ever heard of the IATA Temperature...