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Kevin Owen

Director of Aseptic Technologies - EMEA

Kevin Owen Aseptic Expert
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"Doing the right thing because it’s the right thing to do."

Kevin is an experienced, pharma industry-proven aseptic fill finish SME with over 30 years’ expertise as a senior operations manager and QC laboratory manager. Kevin specializes in ensuring aseptic fill finish design and processes, QC laboratories, ‘specials’ facilities and ATMP facilities are compliant to all operational and regulatory requirements.

A microbiologist by profession, Kevin has managed facilities and products from clinical trials to full commercial capability, and has hands on experience of installing new lines and equipment within cleanrooms whilst still retaining existing commercial capability.

He is regulatory battle-hardened, and has expert knowledge of CGMP and current/future compliance expectations, including the 2022 Annex I revision.

He is unique in supporting end-to-end projects from feasibility to final end stage CQV practices (including dynamic smoke visualization and process simulations) and aseptic operator training.

His operational expertise differentiates him, and he is always patient-centric.

  • BSc Microbiology, University College of Wales, Aberystwyth
  • Chartered Biologist, Royal society of Biology
  • Fellow of the institute of Biomedical Scientist
  • International Society for Pharmaceutical Engineering (ISPE)
  • Parenteral Drug Association (PDA)
  • Pharmaceutical and Healthcare Sciences Society (PHSS)
  • Draft Annex 1 Changes - Are You Ready?" INTERPHEX, May 2022, New York, NY.
  • "Aseptic Manufacturing of Pharmaceutical Products and Understanding Pharmaceutical Sterilization." Ongoing Series, Amsterdam and Copenhagen

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