Introduzione

A robust Quality Management System (QMS) is the backbone of pharmacovigilance, ensuring that the safety profile of medicines is rigorously monitored and maintained.

This course introduces participants to the QMS required in pharmacovigilance.

The objectives of the training are to explore the QMS framework, the different types of audits and their required procedures and management, to consider corrective and preventive actions and to gain insight into the effective management of audit findings.

The programme will also cover important aspects such as training components, maintenance of training records and retention of pharmacovigilance documents. It will also highlight various metrics that are critical to monitoring process compliance and fostering a culture of continuous improvement.

Quality Management System: The Structure

Audit Programme

  • Inbound and Outbound
  • Setting up an Audit Universe
  • Developing an Annual Audit Programme
  • Audit Strategy
  • Tactical and Operational Planning
  • CAPA Management

PV Training

  • Internal & external training
  • Regulatory training
  • Continuous development

Records Management

  • PV document retention
  • Training records
  • Facilities
  • Destruction process

Compliance and metrics

  • Develop and monitor metrics

The course is aimed at pharmacovigilance professionals responsible for quality management activities and metrics, as well as QA professionals will to become an auditor.

Participant experience
Basic Pharmacovigilance experience is required

Interactive training; presentation and workshop exercises

Docente/i
Ranjana Khanna
Info

Ranjana Khanna

Global Director PV QA, BeiGene Switzerland GmbH

Ranjana has a Masters in Technology and a Post Graduate DIploma in Pharmacovigilance. She has been working in this field since 2004, starting her career in Safety Case Processing in a CRO followed by working in various Pharmaceutical companies. Since 2012, Ranjana has been responsible for Pharmacovigilance Quality assurance which includes conducting all types of audits, leading HA Inspections, providing Training and overseeing all QMS aspects. She has led teams globally, presented at several conferences and published articles on aspects of Pharmacovigilance QA.


Online Training – 2 modules

MODULE 1 | 19 November 2024    9:00 am – 1:00 pm CET
MODULE 2 | 21 November 2024    9:00 am – 1:00 pm CET

After the registration, you will receive all details about the connection.

The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.

Early Bird: € 895,00* (until 29 October 2024)

Ordinary: € 1.095,00*

Freelance – Individual – Academy – Public Administration**: € 590,00*

* for Italian companies: +22% VAT

**Early Bird discount not applicable to Freelance – Individual – Academy – Public Administration fee

The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.

Ilaria Butta
Ilaria Butta
Events & Training Manager
Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
Develop the QMS requirements for your organization
Risultato atteso
Develop a basic audit program
Risultato atteso
Setup training requirements
Risultato atteso
Record retention
Risultato atteso
Setup metrics for compliance in your organization

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>

Online interactive training on Zoom platform. 

LS Academy will provide the access link to the virtual platform a few days before the training.

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>