Inspection readiness

Inspections can be a little scary, and so it’s important to be well prepared.  This training covers the inspection process so you and your staff know what to expect.  We cover the specifics of what an inspector will look for and can conduct a workshop session to assess inspection readiness and conduct a gap analysis so you can identify where additional documentation and training might  be needed.

We can also look at what happens after the inspection. How to develop corrective and preventative actions and provide a complete inspection response.


This course will provide delegates with:

  • Information about how inspections are conducted
  • Advice on preparing for inspections and providing information to inspectors
  • Advice on responding to inspection findings

Who it is suitable for:

The course is suitable for all staff who may be involved in an inspection, for example, Clinical Operations Groups, Medical Advisors, CRAs, CTAs, Clinical Project Managers, Investigators, Research Nurses, clinical trial pharmacists, R&D department staff.

Example content:

Regulatory framework covering inspections

  • European and UK inspections
  • FDA inspections

The inspection process

Before – preparation and opening meeting

During – what to expect

After – debrief meeting, report and certificate

Providing information to inspectors

  • Before the inspection
  • Documentation
  • Interview techniques

Potential Consequences

  • 483s and warning letters (FDA)
  • Infringement notices (MHRA)
  • Actions available to regulators

Responding to Inspection Findings

  • Categorisation of findings
  • Writing a CAPA
  • Review and follow up

Please contact me for more information and to organise your course.

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