How to Prepare for a Safety Inspection
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: 3 Elective Units
Regulatory Affairs Certificate Program: 3 Elective Units
For more information go to www.diaglobal.org/certificateprograms
This archive may be purchased through May 7, 2015.
Part 1: 1 hour 59 minutes
Part 2: 1 hour 59 minutes
Part 3: 1 hour 58 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 archived 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
- 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
- Information Technology
- Medical Information
- Risk Management
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
Registration Questions and
Toll Free 1.888.257.6457
Monday-Friday 8:30AM-8:00PM ET
Agenda and Event Logistics
Colleen Buckley, Event Planner
Ways to register
- Individual registration is a license for ONE internet login allowing one viewer.
- Group site registration is a license for ONE internet login allowing multiple viewers from one location.
Cancellations: No refunds will be provided in the event of a participant’s cancellation since all costs for this webinar have been prepaid by DIA. DIA reserves the right to modify or cancel programs and/or substitute presenters or panelists. DIA is not responsible for failure to deliver programs due to circumstances beyond its control.
Participants with Disabilities: Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs