PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation (San Francisco, CA - June 21-22, 2018)

  • ID: 4503613
  • Conference
  • Location: San Francisco, CA
  • 2 Days
  • Compliance Online
  • Conference Dates: June 21-22, 2018
until Apr 29th 2018
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The European Medicines Agency's (EMA) Guideline on good pharmacovigilance practices (GVP), Module IV requires that risk-based audits of the quality system be performed at regular intervals to assure that it complies with the established quality requirements and to determine its effectiveness. It includes audit of the pharmacovigilance system which is covered by the quality system. The GVP Modules are applicable to EU-based companies and any company marketing medicinal products on a global basis. The legally required risk based audit strategy shall cover all PV processes and tasks undertaken by or delegated to other departments, MAH affiliates, and third parties such as distributors, external service providers, partners (the PV Universe). The PV Audit Strategy Plan is used to prepare the PV audit program, i.e. annual PV Audit Schedule.

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..

Seminar Fee Includes:
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar
Download Brochure
Learning Objectives:

Upon completing of this course, participants should be able to:

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

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There will be a 15 minute morning break, 1 hour lunch break, and 15 minute afternoon break on each training day.

Day 1 (8:30 AM 4:30 PM)

8:30 9:00 AM: Registration
9:00 AM: Session Start Time

  • Review of FDA and EMEA requirements for risk based PV audits
  • The pharmacovigilance system and the quality system
  • Strategic level audit planning
  • Hands on exercise
  • PV activities and processes subject to PV audit
  • Risk assessment criteria
  • The PV audit universe all entities subject to PV audit
  • Safety data exchange agreements (SDEAs) and vendor contracts

Day 2 (8:30 AM 4:30 PM)

  • Categorization of the entities (PV Audit Universe)
  • Risk assessments
  • Prioritization of entities for audit according to relative risk
  • 3-5 year PV audit plan
  • Hands on exercise
  • Procedural documents, e.g. SOPs
  • Identify procedures/tools to monitor PV quality for oversight of third parties
  • Q & A
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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
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San Francisco, CA

Venue to be announced shortly.

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