Preparing for MHRA Inspection and Audit

Level
Foundation

Aims
The aim of this course is to provide practical guidance in preparing for and undergoing a local audit and/or MHRA inspection. 

Learning Outcomes
Following the course, participants will be able to:

• Recognise the key differences between quality assurance, quality control, audit and inspection
• Understand the purpose and scope of local audits and MHRA inspections at investigational sites
• Have an awareness of the role and responsibilities of local auditors and MHRA inspectors
• Use a checklist to assemble the key documents required for audit and inspection
• Be familiar with the conduct of both an audit and an inspection
• Summarise the key reporting and reply arrangements generated by an inspection

Programme
The course will cover the following topics:

• The definitions of quality assurance, quality control, audit and inspection
• The purpose and scope of local audits and inspection
• Who are the auditors and inspectors, what are they looking for and how do you prepare?
• Conduct of an inspection
• Reporting and reply arrangements at sites

Further Information
This course is aimed specifically at site-based staff who are unfamiliar with the audit and inspection process. The day comprises a series of presentations with the opportunity for questions and discussion throughout the day.

Duration
This is a one day course.