Charlotte Enghave Fruergaard

Senior Specialist - Aseptic processing, fill and finish

"The industry needs to work on process and performance improvements within the whole life cycle of products, with the ultimate aim to maintain or improve quality and reduce costs."

Charlotte Enghave Fruergaard has more than 20 years of experience with pharmaceutical engineering projects. She has broad experience within pharmaceutical production and is a leading expert within isolator and barrier technology and associated sterilisation techniques. She has extensive experience with filling line projects from business case through performance qualification (PQ).

Charlotte Enghave Fruergaard is former Chairman of the International Board of Directors at ISPE and former Chairman of the ISPE Nordic Affiliate. She is a member of ISPE’s community of practice concerning "Sterile Products Processing". She holds a Ph.D in Metrology from the Technical University of Denmark. She takes on roles as project manager, specialist, consultant, and project engineer in projects concerning aseptic production and in conceptual design studies.

If I can contribute to the production of safe medicines through more effective and better processes and, with that, help our customers to improve quality, then I am doing not only a good job but a fulfilling one, too.

Charlotte Enghave Fruergaard

What's your view on the industry?

"The increasing regulatory requirements combined with the trends in the industry from big blockbusters to smaller batches, and higher need for flexibility and multi-purpose facilities, makes this an interesting and important area of the pharmaceutical industry and the product life cycle.

The industry needs to work on process and performance improvements within the whole life cycle of products, with the ultimate aim to maintain or improve quality and reduce costs.""

Why do you work in this industry?

"These days, pharmaceutical companies face a lot of challenges from regulators all around the world who impose different requirements from industry and competitors. There are even challenges related to criminals, like counterfeiters who try to copy and steal their products. Being able to help and improve our industry’s ability to respond to these challenges is a key driver for me.

If I can contribute to the production of safe medicines through more effective and better processes and, with that, help our customers improve quality, then I am not only doing a good job but also a fulfilling one."

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Expert in:

  • Sterile products
  • Pharmaceutical regulation
  • Risk assessment
  • Aseptic processes
  • Cross contamination assessments
  • GMP compliance and inspection
  • Barrier isolation technology
  • Regulatory affairs
  • Performance quality issues
  • Conceptual design
  • Filling

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