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The Pharmacovigilance Quality Management System Virtual Live Training Course

This course is now fully booked. Next virtual live Pharmacovigilace QMS course is taking place 21-24 September 2021.


Overview

This beginner to intermediate level virtual training course will describe contemporary principles, practical approaches, and regulatory expectations for the Pharmacovigilance Quality Management System. The topics will cover organizational structure, responsibilities, processes and resources required for the pharmacovigilance (PV) system and its quality system. The course employs a mixture of informative instructional sessions, real-world case studies, and hands-on interactive exercises where attendees can apply what they learn. Learners will leave the course with an understanding of how elements of the Pharmacovigilance and Quality Management Systems fit together to achieve regulatory compliance.

A working knowledge of drug safety and pharmacovigilance principles is necessary in order to gain maximum benefit from the course.

 


What participants from the previous virtual QMS course say:

"Highly informative course, detailing every aspect of a well established QMS, in a professional and clear format, delivered by knowledgeable presenters."
Pharmacovigilance Manager, Romania

"Experienced Pharmacovigilance Consultant with a demonstrated history of working in the pharmaceutical industry. A high quality standard in relation to processes and data analysis. Able to act inter- and intradepartmental taken with the focus on teamwork. Acting EU-QPPV. Experienced in case processing, data analysis, EV reporting (ICSRs as well as art57/XEVMPD), compilation of pharmacovigilance system master files (PSMF), initial compilation and maintenance of CCDS and setting up PV systems. EMA and IGJ inspection experience. Eager to transfer knowledge to people in order to make them grow in the field of pharmacovigilance."
Bianca Schrans-Stassen, EU QPPV, Interdos, The Netherlands


 

Featured topics

  • Quality and the Quality System
  • QMS Overview
  • PV System
  • System, Processes, Quality Documents
  • PSMF and PV Quality Manual
  • Risk Assessment of Identified Gaps
  • Procedures and Standards
  • PV in the Clinical Study and Clinical Trial Environment
  • PV Agreements and PV Provisions
  • Commercial Activities and PV Obligations
  • Compliance Management and Monitoring
  • Risk-Based Auditing and the PV Audit Universe
  • Record Management and Documentation of QMS
  • PV Inspections and Inspection Readiness
  • Responding to Inspection and Audit Findings
  • CAPA Plan

 

Who should attend?

This course is designed for professionals involved in:

  • Quality assurance and compliance of the pharmacovigilance system 
  • Pharmacovigilance auditors 
  • Drug safety and pharmacovigilance personnel responsible for compliance, pharmacovigilance agreements, and/or pharmacovigilance quality documents
  • Pharmacovigilance activities at a pharmaceutical company or external service provider

Pharmacovigilance personnel who are considering the Pharmacovigilance Quality Management System field as a future career path would benefit from this course.

 

 

Learning objectives

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

  • Describe how to design, develop, and manage a quality system related to your pharmacovigilance system
  • Explain the components of the Pharmacovigilance Quality Manual 
  • Describe the process for the development and maintenance of the Pharmacovigilance System Master File
  • Analyze how the pharmacovigilance quality system integrates with the pharmacovigilance system 
  • Discuss the development, maintenance, and quality oversight of pharmacovigilance SOPs and pharmacovigilance related documents, including Safety Management Plans and PV Agreements across clinical study programs and post-marketing
  • Assess the effectiveness of the Quality Management System
  • Explain Quality Risk Management Planning for risk-based audits of the Pharmacovigilance System and Quality System
  • Define the scope of pharmacovigilance audits, including process audits, drug specific pharmacovigilance audits, and business partner pharmacovigilance audits
  • Describe how to prepare for audits and inspections
  • Practice preparing responses to a pharmacovigilance audit and inspection findings

 


TECHNICAL REQUIREMENTS

To test your system compatibility, please click on the link: https://diaglobal.zoom.us/test

Operating Systems

  • Windows: XP 32-bit (SP3), 2003, Vista 32-bit/64-bit, Windows 7 32-bit/64-bit
  • Mac OS X: 10.5, 10.6, 10.7
  • Linux: 32-bit Ubuntu 10.x,11.x 32-bit Fedora 15/16, 32-bit Red Hat 5/6, 32-bit OpenSuSE 11.4

Minimum System Requirements

  • Windows: Processor – Requires Sun Java 5 or higher, Recommend ActiveX be enabled for Internet Explorer
  • Mac OS X: Processor – JavaScript and cookies enabled, Requires Apple Java 5 or higher, No support for Remote Access
  • Linux: Processor – JavaScript and cookies enabled, Requires Apple Java 5 or higher, No support for Remote Access

Browsers

  • Windows: Internet Explorer 6, 7, 8, 9, (Win7 Only), Firefox latest (32-bit), Chrome latest
  • Mac OS X: Safari 4-Mar; Firefox 2/3/3.5
  • Linux: Mozilla 1.7, Firefox 2/3/3.5

Internet Connection Speed

  • Windows: Intel or AMD processor (1GHz or faster), At least 512 MB RAM (at least 2 GB RAM for Vista)
  • Mac OS X: Intel processor, At least 512 MB RAM
  • Linux: At least 512 MB RAM

Display

  • 800x600 pixel resolution or greater (1024x768 pixels recommended)

 

Contact us



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+41 61 225 51 51


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+41 79 333 29 76