Audit Readiness: How to Prepare, Present, and Perform Under Inspection
Regulatory inspections and internal audits are one of the most visible and high-pressure events in any pharmaceutical organisation. But they don’t have to be feared — they can be managed with skill, calmness, and preparation.
This instructor-led 3.5-hour masterclass gives GMP professionals the mindset, tools, and behavioural confidence to succeed under MHRA, FDA, or internal inspection. Designed for QA leads, QPs, operational staff and SMEs, this course ensures that your teams know what to expect, how to respond, and how to turn feedback into sustained improvement.
Course Details
Instructor
Paul Palmer
Level
Beginner
Duration
3.5 Hours
Type
Instructor led
Course Content
Why is this course essential?
MHRA and FDA inspectors routinely raise issues that stem not from non-compliance, but from how staff behave, respond, or present documentation under pressure. This course bridges the gap between compliance and confidence.
What does the course cover?
- The mindset of a successful audit — honesty, clarity, and calm
- What regulators are really looking for (hint: not perfection)
- How to prepare audit rooms, back rooms, site walkarounds and documentation
- Pre-inspection checks on documentation, training records, logbooks, and change control
- Training your staff to answer questions factually and professionally
- Avoiding audit behaviour pitfalls (e.g. guessing, overexplaining, defensiveness)
- Managing SME responses, operator walkthroughs and audit stress
- How to respond to findings in a way that builds inspector confidence
- Turning observations into QMS-wide improvements, not repeat gaps
Ideal for?
- Quality Assurance professionals and audit coordinators
- Qualified Persons (QPs) and technical leaders
- Operational staff, line managers and team leads
- Documentation and training coordinators
- Regulatory Affairs and compliance staff
- Anyone likely to support, host, or be interviewed during audit
Benefits:
- Practical, behavioural training for real-world inspections
- Templates for audit prep, tracking and SME briefing
- Tips for answering questions with confidence and control
- Lessons from past MHRA and FDA findings
- Great for teams preparing for licence applications, routine inspections, or client audits
What's Included
3.5Hrs of instructor led learning
Usable documents and templates
Real work examples and exercises
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