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
Course facts
1 day
4 out of 5
Price this year
5.200 DKK excl. VAT
Sign up here
5. sep.

Your advantages when choosing this course

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.

Your 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

Target group

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

Course agenda

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.

Sign up here
5. sep.