Drug Information Association, Inc. , Horsham, PA
Oct 15 2010 8:30AM - 5:00PM
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. WHAT YOU WILL LEARN
• 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:
10414
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