Face-to-face and blended
learning for corporate clients
How to prepare for GCP Audit and Regulatory Inspection
Duration: 1 or 2 days
Key Objectives:
Understand how to prepare for audit and inspection of clinical trials
Learn how to plan for an audit or inspection, including using appropriate checklists
Appreciate how to prepare for audit/inspection Interviews
Consider how to respond to the audit/inspection findings
Who should take this course?
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 Syllabus:
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 – eg EMEA inspection guidelines,
which are part of EudraLex 10
• Sharing experiences of inspections – group discussion
3. Audit/Inspection planning and checklist development for FDA 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 EMA inspection guidelines see Eudralex 10 inspection documents and
some FDA documents – eg 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)
