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PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation
Presented By ComplianceOnline
Saturday, September 18th at 9:30am EST
Online sale ends: 09/18/21 at 8:30am EST
online event
6201 America Center Drive Suite 240 San Jose, CA 95002, USA
San Jose, CA 95002
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Description

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
  • Identify procedures/tools to monitor PV quality of third parties

Presented By

9:30am to 4:30pm
Doors open at 9:30am

Age
All Ages

online event<br> 6201 America Center Drive Suite 240 San Jose, CA 95002, USA<br> San Jose, 95002

18887172436

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