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:
Malene Lund Nielsen, Nordic QMS & Compliance Manager, Novartis-Sandoz
Susan Bordrup, Ethics & Compliance officer, GSK
Malene Grøn, Senior Consultant, Pharmakon

Kursusfakta

Format

1 dag

Pris i år

5.200 kr. ekskl. moms

Tilmeld dig her

Tilmeldingsdatoer

Hillerød

5. sep.

2023

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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.

The course gave me a better understanding of what my colleagues in QA are working with.

Evaluering af kurset

Det har givet nogle nye inputs til prioriteringer sf kvalitetsopgaver.

Evaluering af kurset

Oplæg fra GSK var meget inspirerende.

Evaluering af kurset

Målgruppe

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

Kursusagenda

Kl. 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.

Se ofte stillede spørgsmål og svar

Eller kontakt

Andreas Goldschadt

Kursuskoordinator

+45 48 20 62 63

ag@pharmakon.dk

Tilmeld dig her

Tilmeldingsdatoer

Hillerød

5. sep.

2023

Se alle datoer

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Kurser og konsulentydelser til apotek

Læs om muligheder for kompetenceudvikling og støtte til apotek.

Aktiviteter og kurser til life science

Læs om GMP og GDP, herunder lovgivning, distribution, risikostyring og pharmacovigilance.

Forskning i apotekets rolle og medicinsikkerhed

Læs det seneste om vores forskningsprojekter og udviklingsopgaver.

Konferencecenterets nyhedsbrev

Læs om nyheder og arrangementer, tiltag på konferencecenteret og inspiration fra Pharmakons køkken.

Farmakonomuddannelsens nyhedsbrev

Læs om uddannelsen til dig, der overvejer at blive farmakonomstuderende.

Se eksempler på nyhedsbrevene fra Pharmakon, klik her.

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Risk based GMP management

Proactive management in the company