2024-06-12 2024-06-12 , online online, 1,590 € plus tax Dr. Ilona Schonn https://www.forum-institut.com/seminar/24112054-pharmacovigilance-auditing/referenten/24/24_11/24112054-online-training-pharmacovigilance-auditing_schonn-ilona.jpg Pharmacovigilance Auditing

Do you want to independently plan and conduct pharmacovigilance audits? Then take this opportunity to become an "Auditor for Good Pharmacovigilance Practices". Secure your place on our compact, interactive online course. Book now!

Topics
  • Qualifications and responsibilities according to GVP Module IV
  • Conducting effective interviews
  • Auditing of PV documents, contracts, and SDEAs
  • Expectations of an auditor and inspector
  • Risk-based audit strategy - planning, scheduling, and conducting


Who should attend
This online course is aimed at professionals and managers in the pharmaceutical industry who aspire to, or have recently achieved, the role of GVP auditor and wish to plan and conduct pharmacovigilance audits independently and confidently in the future.

Work experience in pharmacovigilance of more than 3 years is recommended for this course.
Aims and objectives
In just 1.5 days, our compact, interactive training programme will fully prepare you to conduct sound Good Pharmacovigilance Practice (GVP) audits.

After covering the basics of EU regulation, the first day focuses on the key tasks of the auditor: Conducting interviews with PV responsibilities or managers and reviewing various PV documents.
Day 2 begins with a holistic view of all the areas that need to be assessed in a PV audit. Different strategies will be discussed depending on who is auditing whom and the risk-based approach to PV audits will be trained.

During the training our qualified experts will answer many other additional questions such as:
  • Where can I find supporting material such as checklists, templates, and questionnaires?
  • What are the expectations of an inspector regarding the planning, execution, and documentation of an audit?
Your benefit

Take advantage of this compact online training course and conduct future pharmacovigilance audits safely, independently and successfully! The two workshops included will help you consolidate what you have learned and put it into practice.

After the seminar, you will be able to...

  • accompany and conduct pharmacovigilance audits according to the latest regulations.
  • conduct targeted and effective interviews.
  • understand pharmacovigilance contracts and key pharmacovigilance documents in detail.
  • develop risk-based audit strategies and audit plans.

Course Pharmacovigilance Auditing

Pharmacovigilance Auditing

Planning and conducting GVP Audits

Benefits
  • Compact training for new PV auditors
  • Professional speakers from Big Pharma and consulting
  • Interactive format with two workshops
  • Officially certified to the ISO 9001 and ISO 21001 standards

Webcode 24112054

Book now

JETZT Buchen

Speakers


Everything at a glance

Appointment

25-26/11/2024

25-26/11/2024

Period

Day 1: 09:00-17:00 CE(S)T
Day 2: 09:00-13:00 CE(S)T
You may dial in 30 min. before the session

Day 1: 09:00-17:00 CE(S)T
Day 2: 09:00-13:00 CE(S)T
You may dial in 30 min. before the session
Venue

online

online

Fee
Your contact

Nadja Wolff
Conference Manager

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

Details

Do you want to independently plan and conduct pharmacovigilance audits? Then take this opportunity to become an "Auditor for Good Pharmacovigilance Practices". Secure your place on our compact, interactive online course. Book now!

Topics

  • Qualifications and responsibilities according to GVP Module IV
  • Conducting effective interviews
  • Auditing of PV documents, contracts, and SDEAs
  • Expectations of an auditor and inspector
  • Risk-based audit strategy - planning, scheduling, and conducting


Who should attend
This online course is aimed at professionals and managers in the pharmaceutical industry who aspire to, or have recently achieved, the role of GVP auditor and wish to plan and conduct pharmacovigilance audits independently and confidently in the future.

Work experience in pharmacovigilance of more than 3 years is recommended for this course.

Aims and objectives

In just 1.5 days, our compact, interactive training programme will fully prepare you to conduct sound Good Pharmacovigilance Practice (GVP) audits.

After covering the basics of EU regulation, the first day focuses on the key tasks of the auditor: Conducting interviews with PV responsibilities or managers and reviewing various PV documents.
Day 2 begins with a holistic view of all the areas that need to be assessed in a PV audit. Different strategies will be discussed depending on who is auditing whom and the risk-based approach to PV audits will be trained.

During the training our qualified experts will answer many other additional questions such as:

  • Where can I find supporting material such as checklists, templates, and questionnaires?
  • What are the expectations of an inspector regarding the planning, execution, and documentation of an audit?

Your benefit

Take advantage of this compact online training course and conduct future pharmacovigilance audits safely, independently and successfully! The two workshops included will help you consolidate what you have learned and put it into practice.

After the seminar, you will be able to...

  • accompany and conduct pharmacovigilance audits according to the latest regulations.
  • conduct targeted and effective interviews.
  • understand pharmacovigilance contracts and key pharmacovigilance documents in detail.
  • develop risk-based audit strategies and audit plans.

Detailed programme

Day 1: 09:00-17:00 CE(S)T
Day 2: 09:00-13:00 CE(S)T
You may dial in 30 min. before the session

08:45

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

09:00

FORUM Institiut

Welcome and introduction

09:15

Ivana Vukic, MPharm

GVP audits - an overview
  • Responsibilities of the GVP auditor
  • Components of the audit plan
  • Types of PV audits
  • Use of audit checklists, templates, and questionnaires
  • Audit process
  • Report and lean documentation
  • Findings and CAPA

10:45 Coffee break


10:45

Dr. Ilona Schonn

Regulatory framework
  • Legal and GVP requirements
  • Inspection review

11:45

Dr. Ilona Schonn

Efficient PV document review
  • Requesting documents in advance
  • PSMF - does a document really say it all?
  • Reviewing SOPs and quality documents
  • Reviewing RMPs
  • Reviewing PASS, DSUR, PSUR, and PBER
  • Considerations for document review

12:30 Lunch break


13:30

Dr. Ilona Schonn

Auditing contracts, SDEAs and service provider agreements

14:15

Dr. Ilona Schonn, Ivana Vukic, MPharm

The psychology of auditing
  • Auditor attitude and approach
  • Leading questions - effective questioning
  • Objectivity and appreciation

15:00 Coffee break


15:15

Dr. Ilona Schonn, Ivana Vukic, MPharm

Conducting effective interviews
  • Interviewing the QPPV
  • Interviewing PV roles and interface department responsibilities
  • In-process controls, KPIs and compliance

16:00

Dr. Ilona Schonn, Ivana Vukic, MPharm

Workshop: Conducting effective interviews
  • Do's and dont's
  • Role play: The auditor and the auditee

17:00 Day 1 ends


09:00

Dr. Ilona Schonn, Ivana Vukic, MPharm

Wrap-up of the first day

09:15

Dr. Ilona Schonn

Auditing the whole PV system and typical findings
  • Computerized systems and databases
  • Monitoring and case processing
  • Signal management
  • Quality management
  • Risk management

10:15

Dr. Ilona Schonn, Ivana Vukic, MPharm

Discussion: Who are you auditing?
PV system / affiliate / outsourced role /service provider / business partner / ...

10:45 Coffee Break


11:00

Ivana Vukic, MPharm

Audit strategy and tactics: The risk-based approach
  • Planning and scheduling
  • Risks in the PV system
  • Prioritisation methods

11:45

Workshop: Developing a realistic audit strategy
  • Risk assessment and resource planning
  • Audit strategy and annual audit plan

12:30

Dr. Ilona Schonn, Ivana Vukic, MPharm

Summary and discussion

13:00 Seminar ends


Ihr Nutzen

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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In-house seminars

Our programmes are also available for in-house training. Just contact us!

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Abbreviations, Glossary

Many abbreviations are used in all regulatory areas. Download the list of the most important ones.

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Abbreviations, Glossary
We guarantee the highest quality

We are now officially certified to ISO 9001 and ISO 21001 standard.

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We guarantee the highest quality