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

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