PharmaSchool: Preparing for Inspections

Please contact Jo Burmester at jo.burmester@pharmaschool.co.uk to find out more about in-house courses and discuss your specific needs.

Course Code: CTC005

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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

Customised In-house Courses are designed for organisations wishing
to train a group of your employees at a location of your choice.
For information about Open Courses click here or for
online learning click here

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