Risk based Pharmacovigilance audits
Seminar
Online
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DeLSt - Deutsches eLearning Studieninstitut
Kurs FernunterrichtKostenlos -
Academy of Sports
Kurs FernunterrichtKostenlos
Beschreibung
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Kursart
Seminar
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Methodik
Online
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.
Meinungen
Erfolge dieses Bildungszentrums
Sämtlich Kurse sind auf dem neuesten Stand
Die Durchschnittsbewertung liegt über 3,7
Mehr als 50 Meinungen in den letzten 12 Monaten
Dieses Bildungszentrum ist seit 16 Mitglied auf Emagister
Themen
- Audit
Inhalte
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
Interactive online Workshop: Case studies to work out
- PV risks
- An annual audit plan
- A long term audit strategy
17:00 Seminar ends
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
...Risk based Pharmacovigilance audits
-
DeLSt - Deutsches eLearning Studieninstitut
Kurs FernunterrichtKostenlos -
Academy of Sports
Kurs FernunterrichtKostenlos