Customised In-house Courses are designed for organisations wishing to train a group of your employees at a location of your choice.
Duration:
1 day
Description:
Audits and inspections are a fact of life when running clinical trials. This course will provide delegates with:
- Information about how MHRA 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 staff, senior managers, investigators and other site staff.
Example content:
Regulatory framework covering inspections
- European inspections guidance ad legislation
- MHRA 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
Responding to inspection findings
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