2025-11-18 2025-11-18 , online online, 1,290 € zzgl. MwSt. Dr. Petra Lerner-Hiller https://www.forum-institut.de/seminar/26042054-ensuring-quality-in-the-pharmacovigilance-system/referenten/26/26_04/26042054-course-ensuring-quality-in-the-pharmacovigilance-system_lerner-hiller-petra.jpg Ensuring Quality in the Pharmacovigilance System

Are you wondering how to implement the quality requirements of GVP Module I in your organisation? Then this online seminar is just for you! After the training you will be able to monitor and optimise your PV system and you will be well prepared for the next inspection. Book your place now!

Topics
  • Key components and processes of the PV quality system
  • Proper documentation and archiving of critical processes
  • Organisation, responsibility and delegation
  • Effective monitoring
  • Training, audits, CAPA and more


Who should attend
This online seminar is aimed at pharmaceutical manufacturing personnel involved in the implementation, review and ongoing adaptation of the PV system.

Previous knowledge of pharmacovigilance is recommended.
Aims and objectives
A well-organised quality system is the essential basis for a functioning pharmacovigilance system. However, when it comes to practical implementation in pharmaceutical companies, questions often arise:
  • What are the requirements of the PV system?
  • How do I measure quality?
  • How should I tread critical processes?
  • What can be delegated?
  • How do I document and archive?
Our experienced trainers will work with you to cut through the complexity of the PV system and give you a good overview of all aspects relevant to quality with many practical examples. Ask questions at any time and actively participate in the discussions!
Your benefit

Our speakers will show you how your PV system can meet the quality requirements and how it can be improved over time.
After the seminar you will

  • know the main components of the PV quality system.
  • know how to effectively monitor quality.
  • be well prepared for audits and inspections.
  • be able to test and document what you have learnt using the online test provided.

Course - Ensuring Quality in the Pharmacovigilance System

Ensuring Quality in the Pharmacovigilance System

Practical Implementation of GVP Module I

Benefits
  • QM in PV: A compact overview
  • GVP Modul I, SOPs, KPIs, CAPAs and more
  • Includes online test with additional certificate
  • Officially certified to ISO 9001 and ISO 21001

Webcode 26042054

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

27/04/2026

27/04/2026

Zeitraum

09:00-17:30 CE(S)T
You may join the session 30 minutes before

09:00-17:30 CE(S)T
You may join the session 30 minutes before
Veranstaltungsort

online

online

Gebühr
Your contact

Nadja Wolff
Conference Manager

+49 6221 500-696
n.wolff@forum-institut.de

Details

Are you wondering how to implement the quality requirements of GVP Module I in your organisation? Then this online seminar is just for you! After the training you will be able to monitor and optimise your PV system and you will be well prepared for the next inspection. Book your place now!

Topics

  • Key components and processes of the PV quality system
  • Proper documentation and archiving of critical processes
  • Organisation, responsibility and delegation
  • Effective monitoring
  • Training, audits, CAPA and more


Who should attend
This online seminar is aimed at pharmaceutical manufacturing personnel involved in the implementation, review and ongoing adaptation of the PV system.

Previous knowledge of pharmacovigilance is recommended.

Aims and objectives

A well-organised quality system is the essential basis for a functioning pharmacovigilance system. However, when it comes to practical implementation in pharmaceutical companies, questions often arise:

  • What are the requirements of the PV system?
  • How do I measure quality?
  • How should I tread critical processes?
  • What can be delegated?
  • How do I document and archive?
Our experienced trainers will work with you to cut through the complexity of the PV system and give you a good overview of all aspects relevant to quality with many practical examples. Ask questions at any time and actively participate in the discussions!

Your benefit

Our speakers will show you how your PV system can meet the quality requirements and how it can be improved over time.
After the seminar you will

  • know the main components of the PV quality system.
  • know how to effectively monitor quality.
  • be well prepared for audits and inspections.
  • be able to test and document what you have learnt using the online test provided.

Detailed programme

09:00-17:30 CE(S)T
You may join the session 30 minutes before

Technical test
You are welcome to log in a little earlier to test the audio and camera before the event begins

Start of course: Welcome and introduction


Dr Petra Lerner-Hiller

The regulatory framework for the pharmacovigilance system
  • Overview of the legal framework
  • Good Pharmacovigilance Practices (GVP)
  • GVP Module I: Pharmacovigilance and Quality System
  • GVP Module II: The Pharmacovigilance Master File (PSMF)

Coffee break


Dr Sabine Poltermann

Key components and processes of the PV quality system
  • Principles and objectives of a quality management system
  • Identification of "critical" processes
  • Ensuring processes and documentation remain up to date
  • Standard Operating Procedures (SOPs)
  • Practical case studies

Lunch break


Dr Petra Lerner-Hiller

Organisation, responsibility, and delegation
  • Which parts of the organisation are included in the PV system?
  • QPPV responsibilities: What must be handled personally, and what can be delegated?
  • Proper documentation of delegation - Practical examples
  • Effective resource management - Practical insights

Dr Petra Lerner-Hiller

Compliance and monitoring
  • Efficient monitoring of the PV system, including internal processes, license partners, and service providers
  • Key Performance Indicators (KPIs) and their role in compliance
  • Practical examples
  • Common findings during inspections and how to address them

Coffee break


Dr Sabine Poltermann

Training
  • Who requires training and on which topics?
Assessing learning effectiveness
Proper documentation

Dr Sabine Poltermann

Documentation and archiving
  • What must be documented and archived?
  • Archiving methods and regulatory requirements
  • How long should documentation be kept?
  • Ensuring timely availability of documentation

Dr Sabine Poltermann

Audits and CAPA Management
  • Pharmacovigilance Audits
  • Risk based audit approach and planning
  • Effective corrective and preventive actions (CAPAs)

Summary, questions, and closing discussion

End of course


More Information

An interactive seminar with learning assessment and certificate

This event offers a combination of solid theoretical principles, practical workshops, and interactive discussions. To maximise your learning experience, we kindly ask you to keep your camera on whenever possible and actively participate.

After completing the seminar, you will have the opportunity to take a multiple-choice test in the Learning Space to assess your learning progress. Upon successfully passing the test, you will receive a certificate recognized for its compliance with inspection standards, along with your certificate of attendance.

Technical requirements

You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.

We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.

Free pre-meeting and technology check

You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.

The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.

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