This course is designed for clinical research professionals who are faced with an authority inspection or audit. It is ideal for quality managers, project managers, clinical research professionals from biopharma and academic research organisations who have to guide their team through an EMA, FDA. MHRA or other regulatory inspection and want to know what to do before, during and after an inspection or audit.

Course Content: 

1. Introduction and Objectives

 2. Understanding GCP audit/Inspection for Regulatory Affairs and Clinical Trials and Why it is an Essential Part of Quality Assurance of Clinical Trials

• Audit vs. Inspection – similarities and differences

• The concepts of quality assurance and quality control

• GCP regulations re inspection and implications for audit

• Sharing experiences of inspections – group discussion


3. Audit/Inspection planning and checklist development for FDA, Health Canada, and EMA inspections

• Use of other information available to prepare for an audit/inspection and identify areas for attention

• Audit checklists discussion as to what is needed and review some examples of checklists and EU inspection guidelines

This section will focus on common inspection and audit areas to check. This will include reviewing FDA, Health Canada, and EMA inspection guidelines: see Eudralex 10 inspection documents and FDA Warning letters etc.


4. Understand how to manage audit and inspection meetings

• Opening and closing meetings

• What to look out for

• Consideration to areas to audit/inspection e.g.

• - training records

• - regulatory affairs activities

• - quality system

• - archives

• - computerised systems

• - SOPs etc

• Categorising your findings

Will include role play of how to manage an audit or inspection meeting. The session will go through what inspectors look for in different kinds of inspections/audits.


5. Audit/Inspection Interviews

• What sort of questions could auditors/inspectors ask? – this is to help prepare and will use real examples and sharing of experiences


6. How to respond to audit/inspection Report

• Audit reports

• Examples of audit reports

• Review of inspection reports in the public domain


7. Corrective and Preventative Action

• How to respond to inspection report findings

• Identify and find solutions to common time wasting activities in clinical research projects

• The auditor's role in monitoring responses to audit

• Using CAPA (corrective and preventative action – including the MHRA guideline covering responding to inspection findings)