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

Date2021-05-10 - 2021-05-11

Deadline2021-04-30

Venue, USA - United States USA - United States

KeywordsPv audit strategy plan; Pharmacovigilance audit plan; Fda pharmacovigilance audits

Websitehttps://www.complianceonline.com/pharmac...

Topics/Call fo Papers

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
Identify procedures/tools to monitor PV quality of third parties

Last modified: 2021-04-21 03:20:20