by Paradigm Shift Consulting | Jul 14, 2025 | Auditing, Change Control, Documentation, GDP, Inspection, MHRA, Responsible Person, RPi
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’...
by Paradigm Shift Consulting | Apr 11, 2024 | GDP, Inspection, Licensing, Management, Responsible Person, RPi, Training
Why RPs and Management must Work Together The Good Distribution Practice for RPs and Management Course is a comprehensive tutorial, which explores and explains all the chapters of the original EU GDP Guidelines (2013/C 343/01). It is not possible to operate in the...
by Paradigm Shift Consulting | Apr 11, 2024 | RPi, GDP, Licensing, Logistics, Management, MHRA
An RPi, otherwise known as a Responsible Person for import, is now a crucial role for the import of products from the EU. We are now a third country to the EU and vice versa, so the medicinal goods are not parallel traded products but imports. They will need to ensure...
by Paradigm Shift Consulting | Jul 31, 2023 | Training, Cleaning, GDP, Pest Control, Warehouse
This is NOT something you want to discover in your licensed premises! Pest Control – The Wholesaler’s Burden The UK is having increasingly frequent warm summers, and an upward trend in temperatures is likely. The rodent population will likely surge, and...
by Paradigm Shift Consulting | Jul 6, 2023 | Training, Data, Documentation, GDP
Why is Data Integrity Training important? How we generate, maintain and store records, particularly paper and electronic mediums now and in the future is extremely important. Maintaining Data Integrity by having bonafide Data Integrity Training, forms part of your...
