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Virtual

16 oct 2023 9:00 a.m. - 20 oct 2023 1:30 p.m.

(Central Europe Standard Time)

Advanced Pharmacovigilance Audits and Inspections

FULLY BOOKED! This advanced 5-half-day virtual live training course will help participants to 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.

Perspectiva general

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.

 

Temas destacados

  • 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

 

¿Quiénes deben asistir?

Professionals most likely to benefit from this advanced course will have experience in: 

  • Pharmacovigilance
  • Drug Safety
  • Regulatory Affairs
  • Quality Assurance
  • Risk Management
  • Medical Affairs

or holding similar positions within the industry.
A sound knowledge of Pharmacovigilance is a must. A practical experience in audits and inspections is desirable.

 

Objetivos de aprendizaje

On completing this training 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
  • Design a pharmacovigilance audit
  • Evaluate audit documentation
  • Formulate communication strategies with difficult characters, situations with missing documentation and master extreme situations
  • Critique disagreements on audit findings
  • Identify and follow-up on corrective and preventive actions (CAPAs)
  • Prepare for a pharmacovigilance inspection

 

Digital Learning Catalog

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