Risk based GMP management

Proactive management in the company

How can your company and your employees benefit from Quality Risk Management? You will become familiar with the theory and the tools for risk based management in the life science industry.

During inspections, the Danish Medicines Agency focuses on management involvement and responsibility for establishing the company’s quality system. The expectations by the inspectors are not always met, and the inspection results in deviations related to management role.

 

Participate at this course if you want to avoid such a deviation. We present management responsibilities for implementation and surveillance of the basic quality elements. At the course you will meet a manager from life science, who can tell you what risk based management is all about.

 

After the course you will know exactly how to work proactively with risk management, management and evaluation of the quality system, and no one will doubt that you as a manager can handle any GMP risk.

 

The course is a mix of theoretical presentations, cases and workshop.

 

The course language is English.

 

At the course you will meet:

Susan Bordrup, Ethics & Compliance officer at GSK

Malene Grøn, Senior Consultant at Pharmakon

Tina Brouer, Senior Consultant at Pharmakon

Kursusfakta
Niveau
Specialiserede
Format
1 dag
Vurdering
4,59 ud af 5
Pris i år
4.800 kr. ekskl. moms
Pris næste år
4.950 kr. ekskl. moms
Tilmeld dig her
Hillerød
25. aug.
2021
Hillerød
30. aug.
2022

Tilmeld dig bare

Det er fuldstændig omkostningsfrit, hvis du tilmelder dig et kursus, der senere bliver aflyst eller flyttet pga. Covid-19. Vi sender først faktura, når vi ved, at kurset bliver afholdt, og vi flytter gerne din tilmelding til næste kursusdag, så du er garanteret en plads.

Dine fordele ved at vælge dette kursus

Dit udbytte

Your benefits

  • you work proactively to ensure an effective quality system
  • you apply risk management when performing your management tasks
  • you avoid deviations related to management responsibilities at inspections.

Din virksomheds udbytte

The company's benefits

  • your employee ensures that the quality system is effective
  • your employee is keen on the benefits of risk based management
  • your employee knows the Authority expectations to management responsibilities.
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Nem tilmelding
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Målgruppe

Experienced and less experienced employees with management responsibilities at all levels in GMP companies.

Kursusagenda

The course is a one-day course

 

09.00 – 16.30

  • Legal requirements
  • The basic quality elements
  • Risk based management
  • Management responsibilities
  • Personnel
  • Experiences with risk based management

 

The course is a mix of theoretical presentations, cases and workshop.

The course language is English.

Kursusansvarlig
Malene Grøn
Malene Grøn
Uddannelseskonsulent, Cand.pharm.
+45 48 20 61 65
Tina Brouer
Tina Brouer
Uddannelseskonsulent, Cand.pharm.
+45 48 20 62 61
Tilmeld dig her
Hillerød
25. aug.
2021
Hillerød
30. aug.
2022