Save the date for this half-day program at the Royal Sonesta in Cambridge, MA centering on GAMP. The program will include a keynote address, three concurrent breakout sessions, and end with a networking reception.
The afternoon will begin with a plenary discussion, featuring a number of industry experts, about the upcoming draft Computer Software Assurance draft guidance from FDA’s CDRH division This is widely envisaged as a mandate from FDA to rigorously apply risk management to computer validation activities, and designing ‘right size” assurance that software used to support quality decisions can be relied on, while encouraging innovation and optimization of computer software solutions.
The afternoon will split into two parallel tracks; One will focus on validation of software, how to design a risk based approach, best practices to audit Software as a Service providers, and practical examples of validating SaaS solutions in a regulated environment.
The second track will examine new technologies and how they might be advantageous in Life Science companies. Sessions will include an introduction to Artificial Intelligence and Machine Learning to cover what it is, what it is not, and how to approach leveraging it in regulated environments. Complimenting this, you will have the opportunity to understand the core concepts of blockchain technologies, such as the role and needs for distributed ledgers, and hear practical use cases and lessons learned from industry projects. This track session will conclude with some live demos and online tools to help visualize both these concepts.