by Paradigm Shift Consulting | Apr 6, 2023 | Training, GDP
Unaware of non-conformances and deviations? When a lack of adherence or poor attention to detail creeps into the daily activities of a licensed premises, the site can quickly fall into a non-compliant state… It can be all too easy to find yourself choosing to...
by Paradigm Shift Consulting | Mar 24, 2023 | Auditing, CPD Accredited, GDP, Inspection, Management, MHRA, Responsible Person, Training
Introduction to Auditing Are you an RP and want to check and certify auditing skills, or train your team so you can delegate the activity of external audit or self-inspection? Look no further than our CPD Approved Introduction to Auditing online course. This immersive...
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 | Jan 24, 2023 | Inspection, GDP, MHRA
“I don’t know much about the Inspection Action Group. Who are they?” The Inspection Action Group (IAG) could be considered to be the “sharper end” of the MHRA. The IAG has two “wings”: IAG1 concerns itself with Good Manufacturing Practice (GMP), Good...
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 | Inspection, Change Control, Deviations, GDP, Management, MHRA, Non-Conformance, Responsible Person, Training, Warehouse
The MHRA publishes data on common deficiencies discovered during routine inspections of WDA licensed premises. The most common deficiencies were found with examples in regards to each chapter of the EU Guidelines 2013/C 343/01 and the Human Medicine Regulations...
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...
by Paradigm Shift Consulting | Feb 18, 2021 | Responsible Person, Auditing, Change Control, Data, Deviations, Falsified Medicines Training, GDP, Licensing, Management, MHRA, Outsourcing, RPi, Training
The EU Guidance 2013/C 343/01 clearly outlines the 12 duties of an RP (Responsible Person) in Chapter 2.2. Each of these duties will require the RP to have a high standard of knowledge on Good Distribution Practice; meaning that it is crucial that they have extensive...
by Paradigm Shift Consulting | Feb 4, 2021 | Documentation, Data, GDP, Management, MHRA, Responsible Person, RPi, Training
Good Documentation Practice Documentation such as Standard Operating Procedures (SOPs) and records, are a crucial part of an effective Quality Management System (QMS). They make up all procedures, processes and evidence required for you to ensure that you’re in...
