John has more than 23 years of experience providing technical and consulting services in cGMP biopharmaceutical environments. John is an experienced European Qualified Person with a decade's experience of releasing both commercial and clinical material to market. John has a deep understanding of Environmental and Personnel Monitoring deviations and how to evaluate and present batch impact and decide on batch impact. John has presented and defended numerous such decisions to both Commercial Stakeholders and Regulatory Inspectors. John has a real passion for sharing his experiences.
John is a Quality Systems SME. He has in-depth understanding of aseptic processing, biotechnology products (MABs and other therapeutic proteins), sterilization, lyophilization, liquid fill, oral solid dosage, of tech transfer, supply chain qualification, 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 is a Certified ISO Lead Auditor and has significant experience in GMP/ISO compliance auditing of manufacturing facilities and supply chain.