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 | 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 | 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...
by Paradigm Shift Consulting | Jan 6, 2021 | GDP, Change Control, Data, Deviations, Documentation, Management, Responsible Person, Temperature Management, Training, Warehouse
What are Standard Operating Procedures? Standard Operating Procedures (SOPs) are the documents that will set out all of the procedures used by your company, meaning they should mirror these processes. They are the backbone of your company’s Quality Management...
