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 | Mar 22, 2023 | Training, Auditing, Change Control, Data, Deviations, GDP, Inspection, Licensing, Management, MHRA, Non-Conformance, Outsourcing, Paradigm, Responsible Person, Temperature Management, Unlicensed Medicines, Warehouse
GDP for RPs and Management Webinar Online Webinar Struggling to keep up, or lost in the maze of GDP regulations? Do you want to check your business is compliant in Good Distribution Practice? Licence Holder or Senior Management and unsure of what your RP is expected...
by Paradigm Shift Consulting | Sep 6, 2022 | Controlled Drugs, CPD Accredited, GDP, Inspection, Licensing, Management, MHRA, Responsible Person, Training
Controlled Drugs (CDs) are prescription medicines that are controlled under the Misuse of Drugs Regulations (2001) and the Misuse of Drugs Act (1971). You can find the list of controlled drugs here. If you are supplying controlled drugs (CDs) in either the UK or...
by Paradigm Shift Consulting | Dec 21, 2021 | Outsourcing, Auditing, GDP, Licensing, Logistics, Management, Responsible Person, Warehouse
Contracts for Outsourced Activities Contracts are a requirement when working with a third-party service provider (outsourced activities), to be signed by you (the contract giver) and the service provider (contract acceptor), which makes it clear what the...
by Paradigm Shift Consulting | Dec 21, 2021 | Responsible Person, Auditing, GDP, Inspection, Licensing, Management, MHRA, Paradigm, RPi, Training
The Contract RP’s Identity A Contract Responsible Person (Contract RP) plays the same role as a ‘regular’ RP but they are not a direct employee of the company they are an RP for. They should not have any commercial interest in the company that...
