PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation

In this two day workshop conference we will review the EMA and FDA requirements regarding Risk Based Audits of the PV system and Quality System. The course will focus on the design of the PV audit strategy, identification of the PV processes and entities subject to PV audit (define the PV audit universe), development of risk assessment methodology, development of procedures/tools to monitor PV processes and activities, and implementation of the PV audit strategy plan. Additionally, we will review methods of quality oversight and management of third parties performing PV activities.

Topics: pharmacovigilance audit strategy planning, good pharmacovigilance practices, pv audit strategy plan, risk based pharmacovigilance audits, pharmacovigilance audit plan, fda pharmacovigilance audits, pharmacovigilance audit checklist, pharmacovigilance auditing training, fda pharmacovigilance inspections