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The Risk-Based Approach to Pharmacovigilance Audits - A Practical Approach to Design and Implementation
Presented By ComplianceOnline
Thursday, October 1st at 6:00am PST - Friday, October 2nd, 2020
Online sale ends: 10/01/20 at 5:00am PST
Venue to be announced shortly
2479 E. Bayshore Road Suite 260 Palo Alto, CA 94303, USA
Palo Alto, CA 94303
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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

    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

Presented By

6:00am to 12:00pm
Doors open at 6:00am

General Admission: $1,899.00
Group-Max. 10 Attendees: $9,685.00

Venue to be announced shortly<br> 2479 E. Bayshore Road Suite 260 Palo Alto, CA 94303, USA<br> Palo Alto, 94303



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