by Paradigm Shift Consulting | Oct 4, 2019 | Training, GDP, Paradigm
What is Good Distribution Practice (GDP)? Good Distribution Practice Training is a requirement for all personnel involved in the wholesale distribution of medicinal products. Good Distribution Practice is defined as: “Dealings with the guidelines for the proper...
by Paradigm Shift Consulting | Sep 4, 2019 | Training, Paradigm
Paradigm Shift Consulting – who are we? Founded in 2010, we are a specialised consultancy focusing on small and medium sized businesses mainly within the pharmaceutical and private healthcare industries. We pride ourselves in offering high quality services and...
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...
by Paradigm Shift Consulting | Jul 6, 2023 | GDP, Deviations, Documentation, Falsified Medicines Training, Responsible Person, Training, Warehouse
The packaging looks a little different. So what? Falsified Medicinal Products are a constant presence in the supply chain, and could be a serious threat to your health. With many people feeling the squeeze of the economy now, the urge to get quick and cheap medicines...
by Paradigm Shift Consulting | Jun 16, 2023 | Cleaning, GDP, Training, Warehouse
Keeping it Clean Warehouse Cleaning is a necessary and primary function for keeping licensed pharmaceutical premises clean and in compliance with Good Distribution Practice.Autumn brings leaves and dust, Winter brings water and dirt, Spring brings more water and dust,...
by Paradigm Shift Consulting | Jun 13, 2023 | Outsourcing, CPD Accredited, GDP, Management, Responsible Person, RPi, Training
This course has received CPD accreditation. Training Our Outsourced Activities and Responsibilities of the License Holder and Responsible Person course, covers all the expected requirements of both the LH and the RP, in respect to the Quality System. The required...
by Paradigm Shift Consulting | Apr 27, 2023 | Drivers, GDP, Logistics, Outsourcing, Training
DRIVER TRAINING – the demand for trained drivers Haulage management are under constant pressure to urgently fill driving seats to keep stock and goods moving. It is not implausible that promised driver training after hiring (in many cases) may not actually...
by Paradigm Shift Consulting | Apr 27, 2023 | Management, GDP, Responsible Person, RPi, Training, Warehouse
“The quality system is the responsibility of the organisation’s management and requires their leadership and active participation and should be supported by staff commitment” states EU GDP 2013/C 343/01 in Ch. 1, subsection 1. An ongoing problem… As...
