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 | 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 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 | 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...
