Inspection Survival Guide: Being prepared for an MHRA GCP inspection

**Discounts are available for this half- day course, including fully funded places for UoE/NHS Lothian staff and students. Please see funding and discounts section below**

This half-day course gives an overview of the Good Clinical Practice (GCP) inspection process in clinical research settings.

Statutory GCP inspections conducted by the Medicines and Healthcare products Regulatory Agency (MHRA) are an important part of the regulation of clinical trials in the UK. Anyone who sponsors, conducts or supports a clinical trial in humans involving an investigational medicinal product (CTIMP) or a medical device may find themselves face-to-face with an MHRA inspector. What an inspector will be looking for is evidence that trials have been conducted in compliance with applicable legislation and the principles of GCP. It is a daunting prospect for many, but an understanding of what to expect and how to prepare can help smooth the process and lead to a successful inspection outcome.

This course will be delivered online via MS Teams.

If this course is fully booked, please email education@edinburghCRF.ed.ac.uk to be added to the waiting list (please include your name, course name and course date).  

By the end of this course you will learn how to: 

• Be familiar with the MHRA GCP inspection process, from notification to closure
• Know what to consider when planning and preparing for a GCP inspection
• Understand good inspection interview technique and how to answer questions
• Understand how to structure an inspection response and implement effective CAPA 

This course is aimed at anyone who may be involved in an MHRA GCP inspection.

This course is designed for academic, public sector and charity workers and we are offering it at a discounted price for people working in those sectors. It may also be possible to offer places to commercial organisations – please email education@edinburghCRF.ed.ac.uk for further information about availability, applicable booking fees and how to book. 

There are no specific entry requirements for this course.