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 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
• 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

Responding to inspection findings