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.
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
- Interview techniques
- 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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