Paul Harber, Principal

Paul Harber, Principal

Paul Harber has worked in the area of transport validation for over 25 years. His scope of work has ranged from validation of active and passive shippers for numerous clients. In 2014, project work with NGOs in the evaluation of cold chain operations at Ebola vaccine clinical trial sites in Zone 4 countries was a personally rewarding addition to scope of work.

Paul Harber was a founding member of the PDA Pharmaceutical Cold Chain Interest Group. Paul co-authored for the Parenteral Drug Association (PDA) Journal of Pharmaceutical Science and Technology Technical Report No. 39. PDA TR#39 is widely used by both industry professionals and regulators as the definitive reference source for best-demonstrated practices in transport validation. Paul continues to serve on the PCCIG steering committee and regularly presents at the annual PDA meetings. Paul has contributed numerous articles on a variety of subjects related to cold chain including MKT and Stability Studies for Transportation.

For 16 years the scope of Paul’s work at Eli Lilly and Company focused on the qualification of both active and passive shippers in support of clinical and commercial transportation of temperature labile products. He had major roles in defining and specifying the cold chain components and practices necessary to support the commercialization of four Lilly products.

Paul was the interface to all regulatory agencies on issues of transport package qualification. Paul has provided tech transfer support to implement numerous changes and improvements across the supply chain in support of the Lilly API supply strategy.

Paul is the 2008 recipient of Eli Lilly Engineering Excellence Award, a peer selected award acknowledging lifetime engineering achievements at Eli Lilly and Company.