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How to Prepare for a Safety Inspection

Overview

Continuing Education Credits are not available for the archived offering.
This program is a part of DIA's Certificate Program and is awarded the following:
Clinical Safety and Pharmacovigilance Certificate Program: 4 Elective Units
Regulatory Affairs Certificate Program: 4 Elective Units
For more information go to www.diaglobal.org/certificateprograms

This archive may be purchased through April 30, 2016.
Archive duration:
Part 1: 1 hour 56 minutes
Part 2: 1 hour 53 minute
Part 3: 1 hour 52 minutes


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 introductory online course will teach you how to prepare for an audit/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.

 Course Level: Beginner

Featured topics

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

Who should attend?

Professionals who work in:

  • Drug Safety/Pharmacovigilance
  • Regulatory Affairs
  • Quality
  • Compliance
  • Information Technology
  • Medical Information
  • Risk Management
  • Legal
  • Pharmacology

Learning objectives

At the conclusion of this activity, 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

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