Management Consultant

Nicola Spiggelkötter, PhD

 Nicola Spiggelkötter, PhD

Nicola Spiggelkötter has been a freelance consultant since 2009. She provides consultancy for companies in the areas of pharmaceutical logistics, transport service providers, strategy consultancy, validation and qualification based on many years of experience in the pharmaceutical industry. Her other areas of expertise are cold chain and process optimisation.

She is author or co-author of the following chapters of GMP Compliance Adviser:

  • 16.G The role of transport in ensuring the safety and quality of medicines
  • 16.H Regulatory requirements for the transport of pharmaceuticals
  • 16.I Transport conditions
  • 16.J Transport vehicles and shipping containers
  • 16.K Modes of transportation
  • 16.L Monitoring
  • 16.M Risk management in transportation
  • 16.N Qualification of large-scale active systems (trailers)
  • 16.O Qualification of passive insulation boxes
  • 16.P Logistics service providers
  • 16.Q Transport validation