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Online

Jun 06, 2017 11:00 AM - Jun 08, 2017 1:00 PM

How to Prepare for a Safety Inspection

Back to Agenda

Part 2: Module 3, Module 4, and Module 5

Session Chair(s)

Jennifer Kane, BSN, RN

Jennifer Kane, BSN, RN

Head of Pharmacovigilance

Flexion Therapeutics, United States

Module 3 – MHRA/EMA/EU Inspections

Qualified person for PV
Preparation
The Good PV Practices Inspection Module
Types of findings
Pharmacovigilance System Master File

Module 4 - Common Inspection Findings

Module 5 - Responding to the Findings and Preparing the Corrective and Preventive Actions (CAPA)

Theresponse
CAPA

Exercise

Questions/Answers

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