Description: Attendees will gain a practical, risk-based framework for securing cloud environments in full alignment with FDA’s “Use of Cloud Computing” draft guidance, enabling them to implement robust controls that ensure electronic records and signatures remain tamper-proof and audit-ready. Through real-world case studies and interactive exercises, participants will learn to evaluate and select cloud service providers, negotiate security-focused contract terms, and integrate standardised vendor risk-assessment questionnaires into their compliance workflows. The session will provide templates for ALCOA+-compliant SOPs—covering change-control procedures, audit-trail reviews, and anomaly-detection checkpoints—that meet 21 CFR Part 11 requirements for data integrity and maintain data authenticity, accuracy, and availability. By simulating cyber-incident tabletop exercises, attendees will enhance their decision-making skills to prioritise mitigation tactics based on potential impacts to product safety and submission timelines. Ultimately, participants will leave with actionable best practices to formulate a balanced cloud-compliance strategy, design audit-ready documentation packages, and conduct continuous data-integrity monitoring—advancing their professional credibility and driving operational excellence in cloud-based regulatory affairs.
Learning Objectives:
Develop a Risk-Based Cloud Compliance Strategy.
Attendees will learn to implement ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) within Standard Operating Procedures (SOPs).
Learners will practice conducting cyber-incident tabletop simulations to prioritise mitigation tactics and apply standardised vendor evaluation.
