Dave Rushton
Founder
of Paradigm Shift Consulting Limited.
Dave Rushton is Founder of Paradigm Shift Consulting Limited, a Good Distribution Practice Consultancy.
1st and 2nd Party Audit Report and Follow-up
Producing an Audit Report: What Happens Next Once you have planned and performed a first party (internal) or second party (external) audit, it is imperative that you document your findings in a formal audit report. Regulatory inspectors expect a ‘show and tell’...
Good Distribution Practice (GDP) UK: Ensuring Pharmaceutical Quality & Safety
What is “Good Distribution Practice” and why does it matter for ensuring Pharmaceutical Quality and Safety? In the evolving world of the pharmaceutical supply chain, one crucial element often remains behind the scenes: Good Distribution Practice...
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,...