Dave Rushton
Founder
of Paradigm Shift Consulting Limited.
Dave Rushton is Founder of Paradigm Shift Consulting Limited, a Good Distribution Practice Consultancy.
Blog
Take a look through our free blogs that cover a number of different areas of Good Distribution Practice (GDP). Each blog addresses primary topics including training, inspections and procedures. If you need any more information or any assistance/training don’t hesitate to contact us by email or phone.
MHRA Suspended Licence
The MHRA Suspended Licence List is updated regularly with all companies whose licence has been suspended.
Applying for your Wholesale Dealers Licence
We can support you through the WDA application process.
Dummy Recall – What is it? A FREE guide by Senior Associate Bernard Lawlor
*Note* This article is NOT about Asda Cherry Soothers, or other children's dummies being recalled. This is a post on carrying out a dummy recall/mock recall of pharmaceutical products. What is a dummy recall/mock recall? If your wholesale site has not had an active recall during the course...
QMS – Quality Management System
What is a Quality Management System (QMS)? "A system by which an organisation aims to reduce and eventually eliminate non-conformance to specifications, standards, and customer expectations in the most cost effective and efficient manner." or “A set of co-ordinated activities to direct and control...
Duties of the Responsible Person
The EU Guidelines set out the 12 duties of the Responsible Person.
Wholesale SOPs
Your Wholesale SOPs are the backbone of your QMS… but what are they?
Wholesale Dealer Licence Application
Do you know what is required for a Wholesale Dealer Licence Application?
Gold Standard – Responsible Person, Medicinal Products
The Gold Standard for RPs (medicinal products) was released in June 2014.
An Inspector Calls
During an MHRA Inspection an Inspector will be looking for evidence of GDP compliance throughout the company.
Cogent SSC Announce Gold Standard for RPs
Cogent SSC Gold Standard for RPs. Talking of this development, Mark Birse, Group Manager GMDP Inspections at MHRA commented “Responsible Persons play a vital part in ensuring the quality and the integrity of medicinal products are maintained throughout the distribution chain. It’s essential...