How to Prepare for a Safety Inspection

Date(s) And Time(s):
Oct 15 2010 8:30AM - Oct 15 2010 5:00PM

Drug Information Association, Inc.
800 Enterprise Rd Ste 200,
Horsham, PA 19044-3509

Interest Area(s):
Clinical Safety/Pharmacovigilance, Medical Communications, Quality Assurance/Quality Control, Regulatory Affairs


Familiarize Yourself with the Changing Face of Global Pharmacovigilance Inspections
Every pharmacovigilance department will, at one time or another, undergo a governmental or health authority inspection as well as audits by vendors, partners, suppliers, internal auditors and others. The course will teach you how to prepare for an inspection from the time of the receipt of the announcement (or of the arrival of the inspectors at your doorstep) to conclusion of the audit.

• How to prepare for an inspection
• How to prepare a response and corrective action plans
• Different types of inspections and audits from around the world (EMEA, UK MHRA and US FDA)

Learning Objectives:
At the conclusion of this course, participants should be able to:
• Define the types of inspections and audits that exist and how they differ around the world
• Discuss the legal basis for inspections and how inspectors do their job
• Prepare for an inspection: preparing the roadmap, team, tasks, and documents
• Assess how to handle the actual inspection
• Discuss how to prepare the response and CAPA
• Participate in mock inspections

Target Audience:
Professionals who work in:
• Drug safety
• Regulatory affairs
• Quality and compliance
• Information technology
• Medical information
• Risk management

Event Code:

Contact Information:

For detailed program information including faculty and topics, please contact:
Laura Parker
Tel. +1-215-442-6101