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.

アジェンダ

Day 1 2018年3月12日 (月)

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 2018年3月13日 (火)

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