Nordic Affiliate Quality Community of Practice

Who we are

The ISPE Nordic Quality Community of Practice (CoP) is a practitioner-led forum for Quality professionals and leaders across the life sciences industry. It brings together colleagues from Quality, Operations, MSAT, Regulatory, QC, and Digital/IT to exchange experiences, discuss practical challenges, and share approaches that strengthen Quality in regulated environments.

The CoP is focused on practical implementation, peer exchange, and real-life lessons learned. Its purpose is to help make Quality systems more effective, risk-based, and relevant to the realities of modern pharmaceutical and biotech operations.

Mission 

To strengthen Quality as a business enabler by connecting cross-functional perspectives through structured peer exchange, advancing risk-based practices, QMS effectiveness, and digital enablement across the life sciences ecosystem.

What we want to achieve 

  • Connects Quality, Operations, MSAT, Digital/IT, Regulatory and Health Authorities perspectives
  • Focus on QMS effectiveness 
  • Quality Management Risk in Practice
  • Shares implementation cases and lessons learned across regulated environments
  • Quality enablement and digital transformation: AI in GxP
  • Align with ISPE strategy: Patient focus, innovation and Pharma 4.0

What members can expect 

  • Practical case-based discussions
  • Exchange of lessons learned across companies and functions
  • Networking opportunities across the Nordic life sciences community
  • Member events, roundtables, and future topic development shaped by the community

Quality CoP Chairs

Felipe Fontanet
Managing Consultant
GMP Bridge AG
Chair
Tatiane Hedegaard
Director QA Commercial
Genmab
Vice Chair

Steering Committee members to be announced soon.

How to join us? 

Please send email to:

Felipe Fontanet (felipe.fontanet@gmpbridge.com)  

Tatiane Ferreira Hedegaard tatian_ferreira@hotmail.com             

How to join ISPE?  

Register online 

Download an application form, fill and e-mail to: ask@ISPE.org