PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation 2018 covers topics such as:
- Understand the FDA and EMEA’s requirements 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
- Identify procedures/tools to monitor PV quality of third parties
PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation 2018 brings together:
- PV Quality Assurance Staff
- PV Compliance professionals
- Quality auditors
- Pharmacovigilance Auditors
- Relevant Pharmacovigilance Staff
- PV Service Provider Relationship Managers
- MAH Affiliates responsible for Pharmacovigilance
