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NH Berlin Alexanderplatz

Apr 26, 2017 8:30 AM - Apr 27, 2017 4:30 PM

Landsberger Allee 26-32, 10249 Berlin, Germany

How to Prepare for Pharmacovigilance Audits and Inspections

ONLY 1 OFFERING IN 2017! This course will teach you how to prepare for an audit/inspection from the time of the receipt of the announcement to the conclusion.

Overview

NEW IN 2017

Course extended to 2 full days

Every pharmacovigilance function will, at one time or another, undergo governmental or health authority inspections as well as audits by license partners, internal auditors and others. The course will teach you how to prepare for an audit/inspection from the time of the receipt of the announcement (or of the arrival of the inspectors at your doorstep) to the conclusion of the audit or inspection.

What participants from previous course say:
"The instructor was very communicative, engaged the audience to share experience and was answering any question or finding any solution"
"All sessions were interesting and the information provided was really beneficial and useful. Also the interactive sessions, experience sharing and answers to targeted questions were very useful. Most comprehensive I find the preparation for audits part"

Who should attend?

Professionals who work in:

  • Pharmacovigilance/Drug safety (QPPV)
  • Regulatory Affairs
  • Quality & Compliance
  • Medical Information
  • Risk Management
  • Compliance
  • Pharmacovigilance Auditors
  • Management Staff Responsible for Running Inspections
  • Employees (directly and indirectly) Involved in Inspections

Course level: Intermediate (for professionals with 2-3 years of experience in Pharmacovigilance) and Beginner (for professionals with experience within pharmacovigilance auditing area)

Learning objectives

At the conclusion of this course, participants will be able to:

  • Participate in audits/inspections and mock audits/inspections
  • Assess how to handle the actual audit/inspection and responses to requests and findings based on the:
      • understanding of audit/inspection methodology
      • the legal basis of inspections or
      • the contractual basis of audits
  • Prepare responses to audit/inspection findings, including responses and corrective/preventive action (CAPA) plans
  • Prepare their function for an audit/inspection: roadmap, teams, tasks, and documents
  • Assess regional differences with respect to European and US FDA inspections

Participants will complete a knowledge check at the end of the course and will be provided with feedback to ensure learning objectives are attained.

Plan Your Team's Professional Development

The world of health care product development is rapidly evolving. To keep you at the forefront, DIA offers a broad selection of expert-led training courses in the key disciplines of Regulatory Affairs, Clinical Research and Pharmacovigilance, as well as courses created to develop other key competencies in the area of e.g. Biosimilars or HTA.

DIA can deliver this course at your organisation on dates that suit you. Our offerings can be customised to meet your exact needs. Learn how DIA can bring our outstanding training programmes directly to you and your team.
For more information please contact EMEA@diaglobal.org.

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