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 | 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...
