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 | 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 | 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...
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...
