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2021 - PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation
Date2021-09-16 - 2021-09-17
Deadline2021-09-06
VenueVirtual Seminar, USA - United States 
KeywordsPv audit strategy plan; Pharmacovigilance audit plan; Fda pharmacovigilance audits
Topics/Call fo Papers
Day 01(9:30 AM - 5:30 PM EDT)
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 - 5:30 PM EDT)
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
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 - 5:30 PM EDT)
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
Other CFPs
- Navigating through Maze of In-vitro Diagnostics (IVD) Regulations: A systematic approach from Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada
- Change Control Best Practices - Avoiding Unintended Consequences of Changes
- Technical Writing for Pharma, Biotech and Medical Devices
- Regulatory Compliance for Dietary Supplements in the US, EU and Canada
- 9th International Conference on Signal and Image Processing (SIGL 2022)
Last modified: 2021-07-17 14:30:16