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Mercure Paris La Défense Grande Arche

Apr 19, 2016 12:30 PM - Apr 20, 2016 4:30 PM

17/20 Esplanade Ch. de Gaulle - Rue des Trois Fontanot, 92000 Nanterre/Paris, France

How to Prepare for PhV 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 of the audit/inspection.

Agenda

Day 1 Apr 19, 2016

12:30 PM — 1:00 PM

REGISTRATION

1:00 PM — 3:00 PM

SESSION 1: AUDITS IN PHARMACOVIGILANCE

3:00 PM — 3:30 PM

COFFEE BREAK

3:30 PM — 5:00 PM

SESSION 2: EUROPEAN AND FDA INSPECTIONS

5:00 PM — 6:00 PM

DRINKS RECEPTION

Day 2 Apr 20, 2016

8:30 AM — 10:00 AM

SESSION 3: PHARMACOVIGILANCE REQUIREMENTS AND FINDINGS

10:00 AM — 10:30 AM

COFFEE BREAK

10:30 AM — 12:00 PM

SESSION 4: RESPONDING TO THE FINDINGS AND PREPARING THE CAPA

12:00 PM — 1:00 PM

LUNCH BREAK

1:00 PM — 2:30 PM

SESSION 5: ONSITE AUDIT/INSPECTION

2:30 PM — 3:00 PM

COFFEE BREAK

3:00 PM — 4:30 PM

SESSION 5 CONT: ONSITE AUDIT/INSPECTION

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How to Prepare for PhV Audits and Inspections

Agenda

Be informed and stay engaged.