This is an expansion of the “Blockchain for Pharmaceutical Engineers” article in the Jan-Feb 2019 edition of Pharmaceutical Engineering® magazine. The first part of the webinar will provide an introduction into the technology, demonstrate some of the technical components, and discuss use cases within the industry. The second part will diver a bit deeper into considerations for using opensource decentralized networks within regulated processes.
James Canterbury is a Principal working with EY’s Risk Advisory practice where he is part of the global blockchain team, focused on Life Sciences product quality and compliance. He helps his clients understand new technologies and how they might be applied to solve real-world problems. Specifically for blockchain he works to educate clients on the new technology and designs solutions to capitalize on the benefits of a blockchain network when designing efficient, transparent, and trusted solutions. He has 15 years of experience helping biopharma companies find innovative answers to the challenges created by operating in a highly regulated industry. Before blockchain, he primarily managed projects that span from interpreting FDA regulations to privacy & security to financial controls. James holds a BS in Industrial Engineering from Penn State University and is a Certified Information Systems Auditor. He currently sits on the board of the NJ chapter of ISPE, is the Co-Chair of GAMP Steering Committee, and leads the GAMP blockchain special interest group.
Edgar Röder studied Chemistry and Computer Science. He worked in an IT department in the 90s, then as a consultant on ERP Systems (Navision). Since 2004, he advises companies in the life sciences industry on the validation of computerized systems and the compliant operation of IT-infrastructure. He is an IT Auditor (CISA) and engages in several professional associations (ACM, ISACA, GAMP-Forum, ISPE). Since 2017, he is leading the SIG Cloud Computing of ISACA Germany Chapter and in 2018 he founded the local Blockchain SIG of the GAMP-DACH Forum.