Meet the Experts

Your webinar hosts for Understanding Compliance to Container Closure Requirements in the Revised EU GMP Annex 1.

Andrew Larrigan

Technical Operations Manager

Andrew is an expert in transport simulation and cold chain shipping validation. As the Technical Operations Manager, he leads a team of engineers in the Advantage Transportation Simulation Laboratory™ which provides valuable data on the impact of distribution environmental hazards on the critical-to-quality attributes of drug products. He has worked on 100+ products, including biologics, mRNA, cell and gene therapies, pharmaceuticals, combination medical device products, and more for products approved all over the world.  

Andrew has worked on projects in support of clinical trial operations in developing nations to implement mitigations strategies for cold chain distribution of life-saving vaccines and treatments. When clients are dealing with cold chain challenges, Andrew helps them find solutions. Andrew helps customers understand what testing needs to be done in their specific situations. Using the results from a risk assessment of each supply chain, Andrew helps design the needed transport simulation to ensure product quality through distribution.

Carson Dickey

Senior Consulting Engineer

As Senior Consulting Engineer, Carson has developed transport validation strategies for over 30+ products. This consists of developing a validation master plan, conducting risk assessments, developing protocols to demonstrate product robustness, and qualification of thermal packaging. This involves designing his own thermal/physical qualification studies, as well as evaluation of manufacturer-conducted qualifications.

Carson works alongside other consulting engineers at Modality Solutions to provide design and validation engineering services by conducting thermal packaging design and qualification for environmentally-sensitive drug products. Carson also serves as a key technical liaison with your development team. He provides assistance with new drug product transport simulation test design, risk assessment, and protocol development.