2021 - PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation

Day 01(9:30 AM - 4:30 PM EST)
09.30 AM: Session Start
Review of FDA and EMEA requirements for risk based PV audits
The pharmacovigilance system and the quality system
Strategic level audit planning
Hands on exercise
PV activities and processes subject to PV audit
Risk assessment criteria
The PV audit universe - all entities subject to PV audit
Safety data exchange agreements (SDEAs) and vendor contracts
Day 02(9:30 AM - 4:30 PM EST)
Stability (shelf-life) studies
Categorization of the entities (PV Audit Universe)
Risk assessments
Prioritization of entities for audit according to relative risk
3-5 year PV audit plan
Hands on exercise
Procedural documents, e.g. SOPs
Identify procedures/tools to monitor PV quality for oversight of third parties
Q & A