Presenter at Tema Renrum 2025

Read more about Lenes presentation below

Lene Blicher Olesen

Niras, Denmark

Lene has more than 25 years of experience in the biopharmaceutical industry, with focus on environmental monitoring, microbiology, cleanrooms, isolators and aseptic processing.

Furthermore, Lene is chairperson of the Danish Cleanroom Society at Danish Standards, chairperson of the Nordic cleanroom society R3 Nordic, and board member at ICCCS.

Lene has a degree in Engineering in Chemistry and Microbiology, Technical University of Denmark, Engineering Business Administrator, Copenhagen University College of Engineering (2004) and Master of Public Governance, Copenhagen Business School & University of Copenhagen (2015)

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Presentation:

Preparing a Contamination Control Strategy according to EU–GMP Annex 1

According to EU-GMP Annex 1 revision 2022, relevant companies should prepare a Contamination Control Strategy (CCS). The topics that could be addressed in this CCS are given in EU-GMP Annex 1. This presentation gives input on how the CC can be evolved.

The presentation will cover:

  • Background in EU-GMP Annex 1
  • Subjects to be covered in the Contamination Control Strategy document
  • Useful tools and considerations
  • Summary
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