; Online-Course Risk based PV audits
2022-02-17 2022-02-17 , Online Online, 1.090,- € plus tax Mara Dinkel https://www.forum-institut.com/seminar/22022052-pv-audits-inspection-strategies-day-1-risk-based-pv-audits/referenten/22/22_02/22022052-online-course-risk-based-pv-audits_dinkel-mara.jpg PV audits & inspection strategies - Day 1: Risk based PV audits

Our experts will help you to identify risks in your PV system and will provide you with helpful methods to adjust your audit processes and strategies. Save your place in our virtual seminar room.

Topics
  • PV risk identification
  • Methods for the evaluation of risk factors
  • Examine evolving global pharmacovigilance regulations and the impact on your audit strategy
  • Long term audit strategies
Aims and objectives
A risk based audit approach helps to identify the areas of highest risk to the organisation's pharmacovigilance system, including its quality system for pharmacovigilance activities. Moreover, it acknowledges the internal audit to provide assurance to the authorities that the risk management processes are managing risks effectively.

After attending the online-seminar you will be able to
  • prepare a strategic long term plan,
  • identify the PV activities and processes subject to PV audit and
  • develop risk assessment criteria.
Who should attend

This online-seminar will be of benefit to all those working in the pharmaceutical industry who need to handle pharmacovigilance audits successfully.

Especially the following professionals are invited:

  • PV Quality Assurance Staff
  • PV Compliance professionals
  • Quality auditors
  • Pharmacovigilance auditors

Online-Course Risk based PV audits

PV audits & inspection strategies - Day 1: Risk based PV audits

Benefits
  • Interactive online format
  • Firsthand information
  • Meet the experts!
  • We are following the IMI quality criteria

Webcode 22022052

Book now

JETZT Buchen

Speakers


Everything at a glance

Appointment

17.02.2022

17.02.2022

Period

09:00-17:00You may dial in 30 min. b...

09:00-17:00
You may dial in 30 min. before the session
The times for breaks at online-seminars are scheduled individually.
Venue

Online

Online

Fee
Ihr Ansprechpartner

Sonja Wittemann
Conference Manager

+49 6221 500-696
s.wittemann@forum-institut.de

Details

Our experts will help you to identify risks in your PV system and will provide you with helpful methods to adjust your audit processes and strategies. Save your place in our virtual seminar room.

Topics
  • PV risk identification
  • Methods for the evaluation of risk factors
  • Examine evolving global pharmacovigilance regulations and the impact on your audit strategy
  • Long term audit strategies
Aims and objectives

A risk based audit approach helps to identify the areas of highest risk to the organisation's pharmacovigilance system, including its quality system for pharmacovigilance activities. Moreover, it acknowledges the internal audit to provide assurance to the authorities that the risk management processes are managing risks effectively.

After attending the online-seminar you will be able to

  • prepare a strategic long term plan,
  • identify the PV activities and processes subject to PV audit and
  • develop risk assessment criteria.

Who should attend

This online-seminar will be of benefit to all those working in the pharmaceutical industry who need to handle pharmacovigilance audits successfully.

Especially the following professionals are invited:

  • PV Quality Assurance Staff
  • PV Compliance professionals
  • Quality auditors
  • Pharmacovigilance auditors

Detailed programme

09:00-17:00
You may dial in 30 min. before the session
The times for breaks at online-seminars are scheduled individually.

09:00

Introduction and technical warm-up

09:05

Mara Dinkel

Risk based audit strategy - Regulatory framework

10:00 Coffee break


10:15

Mara Dinkel

PV risk identification
  • Which aspects and elements need to be considered?
  • Defining the risk(s) for risk assessment purposes
  • Risk assessment stages
  • Key risk factors in PV

11:30

Mara Dinkel

Methods for the evaluation of risk factors

12:30 Lunch break


13:45

Anika Staack

Examine evolving global pharmacovigilance regulations and the impact on your audit strategy

14:15

Anika Staack

Long term audit strategies
  • Points to consider
  • Calculation of budget and manpower
  • Online audits vs. on-site audits
  • Monitoring of the global audit programme
  • How to deal with deviations

15:30 Coffee break


15:45

Anika Staack

Excursus: online audits

16:00

Anika Staack

Interactive online Workshop: Case studies to work out
  • PV risks
  • An annual audit plan
  • A long term audit strategy
  • Online vs. face-to-face audits - considerations

17:00 Seminar ends


Objectives

Objectives

  • Network with colleagues and meet regulators
  • Share experience and ideas in a neutral environment
  • Practial hints and tips "for take away"
  • Excellent networking possibilities
  • This expertise will benefit your company

Booking options

Get ready for your next pharmacovigilance inspection!

In order to ensure that marketing authorisation holders comply with pharmacovigilance obligations, competent authorities conduct pharmacovigilance inspections at specific intervals. Our workshop PV inspection readiness on day 2 will provide insights into the current pharmacovigilance inspection strategies.

Please find further information with the webcode 2202203.

This distinguishes our events

Overall score of all evaluations in 2020

Five stars on Trustpilot = Excellent

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Go forward

Seminar bundle

We would also like to draw your attention to our seminar "PV Inspection Readiness" (on 18 February).

Details
Seminar bundle
List of abbreviations

Our list of abbreviations can be freely downloaded here.

Details
List of abbreviations
Quality guaranteed!

Your feedback produced as result of 1.7 in 2020. Thank you!

Details
More on our quality criteria

Testimonials


You met and exceeded my expectations because we got a lot of practical examples.


I learned much more than expected. Very helpful.


If you have little knowledge about risk based PV audits please visit this seminar. Great opportunity to learn.

Dr. Marina Röderstein

Otsuka Pharmaceutical Development & Commercialisation Europe GmbH


Very well organized. Excellent speakers.

Liang-Ni Wu

Merck Healthcare KGaA


I really like this seminar. It was interactive.


The seminar fully met my expectations.