Understanding inspections and strengthening audit readiness across regulated environments 

OVERVIEW:

This ½-day training session provides a focused introduction to the regulatory audit landscape for life science organisations, with specific attention to the evolving expectations of agencies including the MHRA (UK), FDA (US), and EMA (EU). 

Participants will gain an understanding of: 

• How regulatory expectations have shifted in recent years due to increased digitisation, unannounced inspections, and post-Brexit territorial changes. 

• The structure and phases of regulatory inspections, from planning through reporting and follow-up. 

• Best practices to achieve continuous audit readiness, including effective documentation, data integrity, QMS design, and staff preparedness. 

The course is suited for staff in quality assurance, compliance, operations, regulatory affairs, and supply chain roles—especially those involved in inspection preparation, CAPA management, or audit response. 

By the end of the session, attendees will be able to anticipate inspection trends, describe audit phases, and contribute to a robust inspection-ready culture. 

CONTENT:

1. Evolving Regulatory Landscape – 2025 and Beyond 

• Overview of current inspection trends: 

• Rise in unannounced inspections, especially by the FDA. 

• MHRA’s adoption of remote and hybrid auditing models. 

• EMA and FDA emphasis on data integrity, digital systems, and cross-border transparency. 

• Inspection reforms under the Windsor Framework and post-pandemic regulatory adaptations. 

2. Common Regulatory Focus Areas 

Identifies frequent findings across MHRA, FDA, EMA: 

• Data Integrity lapses (e.g. audit trail manipulation, third-party testing risks) 

• Quality Management System (QMS) weaknesses 

• Inaccurate or incomplete documentation 

• Inadequate testing/laboratory controls 

• Supply chain vulnerabilities (e.g. lack of traceability or supplier oversight) 

3. Structure and Phases of Regulatory Audits 

Outlines the audit life cycle with expectations at each stage: 

• Planning & Preparation – scoping, risk assessment, identifying audit focus. 

• On-Site/Remote Assessment – interviews, walkthroughs, document review. 

• Reporting & Corrective Action – writing reports, agreeing CAPAs. 

• Follow-Up – verification of actions, final closeout. 

Includes real-world exercises for each phase (e.g. audit trail evaluation, preparation checklist). 

4. Best Practices for Audit Readiness 

• Establishing an effective QMS that incorporates: 

• Internal audits 

• Procedure review cycles 

• Document version control 

• Preparing documentation before audit day: ensuring completeness, access, and traceability. 

• Staff training and inspection protocol awareness 

• Conducting mock audits to assess readiness and reduce last-minute gaps. 

5. Practical Steps to Strengthen Readiness 

Summarised checklists and strategies include: 

• Staying current with regulatory changes 

• Ensuring supply chain visibility and supplier qualification 

• Promoting staff understanding of roles during audits 

• Maintaining training records and digital traceability systems 

6. Comparing MHRA, FDA & EMA Approaches 

Highlights similarities and differences: 

• All follow a risk-based inspection model. 

• FDA often issues public warning letters and has unique U.S. enforcement pathways. 

• EMA and MHRA align with EU law and emphasise harmonised global standards. 

• All agencies require CAPA responses, with escalating consequences for non-compliance. 

7. Group Exercises and Case Studies 

• Realistic audit scenarios exploring potential gaps 

• Exercises on preparing for remote vs. on-site inspections 

• Agency match-up activities and knowledge checks