Login

Register

  • Dates

  • Topics

  • Formats

  • Organiser

Organiser: DIA

This advanced 5-half-day virtual live training course will help participants professionally prepare for PV audits and inspections. Experienced instructors who do audits and participate in inspections on a daily basis will share their experience, tips and tricks and best practices.

Using pharmacovigilance audit techniques allows a company to identify any existing gaps or risks in their systems and procedures. This allows them to define and establish priorities and company compliance.

Participants will learn how to prepare for an audit and inspection in order to achieve best practices from the moment of facing the auditing/inspection visit notification to the moment of receiving the report and its conclusions.

Featured topics

  • PV Audits - QMS Requirements from GVP
  • PV Audit Universe
  • Building a Strategic/Tactical PV Audit Planning
  • Operating Individual PV Audits
  • PV Inspection Readiness
  • Management of PV Inspection
  • Management of Post-PV Inspection Activities

At the conclusion of this course, participants will be able to:

  • Plan pharmacovigilance audits based on risk assessment
  • Identify and address the different areas of a pharmacovigilance system through audits
  • Conduct a pharmacovigilance audit
  • Evaluate audit documentation
  • Manage communication with difficult characters, situations with missing documentation and master extreme situations
  • Handle disagreements on audit findings
  • Identify and follow-up on corrective and preventive actions (CAPAs)
  • Host and manage a pharmacovigilance inspection
Register
Available Dates

Reading this content is completely free

Enjoy Unlimited Access and Unlock
Additional Features with a Free Account

Join Now

You are attempting to log out of MyMA

Do you really want to log out?

Logout
Close