Quality Oversight

Expected by the authorities

The term Quality Oversight and its importance for the Quality Management System in the company is in focus. Expectations and improvements in the process from surveillance to oversight are discussed at the course.

The Authorities expect that companies in life science have oversight of their quality data to ensure consistent quality throughout the product lifecycle.

Experts from life science present how they work with Quality Oversight, quality culture, quality mindset and responsibilities. You will learn how to use quality metrics and drive the process for a quality culture internally and externally regarding CMOs and suppliers.

The authorities’ expectations to Quality Oversight will be presented. At the course we focus on, how you can work with Quality Metrics as a driver for both behavior and culture within the company. We discuss how you can work with quality metrics and quality culture and hereby contribute to the quality oversight in the company.

The course consists of presentations from experts and discussions based on your own experiences.

The course language is English.

At the course you will meet:
Birthe Laustsen, Head of QA, Viatris Denmark
Malene Metz Mørch, Senior Director, Qualified Person, ALK
Ulla Thinggaard, QA Director, Qualified Person, Novo Nordisk A/S
Mette Marie Juul Sørensen, Senior Consultant, Pharmakon

1 dag
3,75 ud af 5
Pris i år
5.200 kr. ekskl. moms
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Dine fordele ved at vælge dette kursus

Dit udbytte

Your benefits

  • you contribute to the work with Quality Oversight in the company
  • you understand how to get from surveillance to oversight
  • you join a valuable networking group.

Din virksomheds udbytte

The company's benefits

  • your employee knows the expectations from the authorities to Quality Oversight
  • your employee uses Quality Metrics as a driver for behavior and culture
  • your employee ensures Quality Oversight at CMOs and suppliers.
It was great to be inspirer by how things are done other places. And a good over view of what Quality oversight can be.
Evaluering af kurset
Good diskussions and fine presentations
Evaluering af kurset


Experienced employees with responsibility for GMP compliance e.g., managers, specialists and QPs.


Kl. 09.00-16.00

  • Expectations from the Authorities
  • Quality Culture
  • Quality Oversight with CMOs and suppliers
  • From expectations to practical implementation
  • From surveillance to oversight

 The course consists of presentations from experts and discussions based on your own experiences.

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