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Adina Apartment Hotel Berlin Checkpoint Charlie

Mar 12, 2018 8:00 AM - Mar 13, 2018 4:30 PM

Krausenstrasse 35-36, 10117 Berlin, Germany

How to Prepare for Pharmacovigilance Audits and Inspections

This course will teach you how to prepare for an audit/inspection from the time of the receipt of the announcement to the conclusion.

Agenda

Day 1 Mar 12, 2018

8:00 AM — 8:30 AM

REGISTRATION

8:30 AM — 10:00 AM

QUALITY SYSTEM IN PHARMACOVIGILANCE

10:00 AM — 10:30 AM

COFFEE BREAK

10:30 AM — 12:00 PM

AUDITS IN PHARMACOVIGILANCE

12:00 PM — 1:00 PM

LUNCH

1:00 PM — 2:30 PM

EUROPEAN AND FDA INSPECTIONS

2:30 PM — 3:00 PM

COFFEE BREAK

3:00 PM — 4:30 PM

EUROPEAN AND FDA INSPECTIONS

4:30 PM — 5:30 PM

NETWORKING RECEPTION

Day 2 Mar 13, 2018

8:30 AM — 10:00 AM

PHARMACOVIGILANCE REQUIREMENTS AND FINDINGS

10:00 AM — 10:30 AM

COFFEE BREAK

10:30 AM — 12:00 PM

RESPONDING TO THE FINDINGS AND PREPARING THE CAPA

12:00 PM — 1:00 PM

LUNCH

1:00 PM — 2:30 PM

ONSITE AUDIT/INSPECTION

2:30 PM — 3:00 PM

COFFEE BREAK

3:00 PM — 4:30 PM

ONSITE AUDIT/INSPECTION

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How to Prepare for Pharmacovigilance Audits and Inspections

Agenda

Be informed and stay engaged.