Mr. John Henchion, Qualified Person, Commissioning Agents has more than 20 years of experience providing technical and consulting services in cGMP pharmaceutical and biotechnical environments. John is an experienced QP with several years’ experience releasing both commercial and clinical material to market. John is a Quality Systems SME. He has in-depth understanding of aseptic processing, biotechnology products (MABs and other therapeutic proteins), oral solid dosage, liquid fill, lyophilization, sterilization, bulk chemical API, and medical devices. He understands FDA and EU regulations, regulatory guidance documents, and ICH guidelines and has applied the knowledge to develop risk based approaches for several applications. John has significant experience in GMP compliance auditing of manufacturing facilities and supply chain. He is familiar with implementation of Lean principles and tools, Kaizen events, root cause analysis, visual workplace, standardized work and process mapping of supply chain. John has held leading roles in both large greenfield and brownfield C&Q projects that have delivered operational ready Biotech facilities to the Client.