PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation 2021
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.
Learning Objectives:
Upon completing of this course, participants should be able to:
- Understand the legal requirements and health authority expectations for a risk based audit program and current interpretation. Plan, develop and implement the PV Audit Strategy Plan, which includes the following processes:
- Develop a high-level PV audit strategy
- Identify the PV activities and processes subject to PV audit
- Develop risk assessment criteria
- Identify the PV audit universe – entities subject to PV audit
- Categorize the entities subject to PV audit
- Perform risk assessments
- Prioritize entities for audit according to relative risk
- Prepare a 3-5 year PV audit plan
Who will Benefit:
This course is designed for people with some PV experience and tasked with developing, maintaining, updating and/or reviewing the PV quality system audit strategy plan, risk assessment and/or the annual PV audit schedules. It is also beneficial for staff responsible for the quality oversight of third parties conducting PV activities.
The following personnel will benefit from the course:
- PV Quality Assurance Staff
- PV Compliance professionals
- Quality auditors
- Pharmacovigilance Auditors
- Relevant Pharmacovigilance Staff
- PV Service Provider Relationship Managers
- MAH Affiliates responsible for Pharmacovigilance
