Day Two Agenda
Thursday, July 17, 2025
8:30 am Check In & Light Breakfast
9:20 am Chair’s Opening Remarks
Maximizing Security Frameworks to Ensure Safety of Data
9:30 am Cloud Systems Cybersecurity Considerations
Synopsis
- Fundamentals to ensure your Cloud Provider is truly secure
- Authentication and using AI to detect anomalies and enable risk-based access
- Balancing strong protection with frictionless user access
10:00 am Securing AI Systems During Training and Deployment to Protect Your AI Model
Synopsis
- Protect data integrity with encryption, access controls, and adversarial defense
- Prevent tampering with robust authentication, monitoring, and container security
- Use AI-driven monitoring to detect vulnerabilities and mitigate attacks in real time
10:30 am Strategies to Meet FDA Cybersecurity Requirements While Using Cloud Providers
Synopsis
- Ensure clear division of security responsibilities between your organization and cloud providers to meet FDA compliance
- Use continuous monitoring, threat detection, and AI-driven analytics to proactively manage cybersecurity risks
- Integrate FDA cybersecurity requirements into cloud-based medical device development from the start
Ensuring Cross-Functional Alignment to Ensure Cloud Compliance
11:00 am Translating Cross Functionally to CSV Experts to Showcase Accurate Deliverables Required
Synopsis
- Communicating compliance needs clearly to CSV (Computer System Validation) experts to align technical and regulatory goals
- Establishing clear validation documentation, test scripts, and compliance checkpoints
- Implementing structured workflows, shared responsibilities, and cross-functional training to ensure seamless validation processes
11:30 am Morning Break
12:00 pm Understanding Organizational Change Management (OCM) & Strategizing to Ensure Expectations Brought by This Change Are Addressed Across All Functions
Synopsis
- Understanding the role of OCM in managing regulatory and operational shifts, especially in compliance environments
- Ensuring clear communication, stakeholder involvement, and understanding of new compliance requirements throughout the organization
- Establishing feedback loops, training programs, and continuous monitoring to address challenges and optimize long-term success
12:30 pm Panel Discussion: Who Does Data Governance, Data Security, & Chain of Custody Lie With? What Are the Controls in Place Internally to Ensure Data Governance?
Synopsis
- As data moves across systems, who should be accountable for governance, security, and chain of custody, and how can we ensure these responsibilities are clearly defined and effectively shared?
- Implementing access controls, data classification policies, audit trails, encryption, and regular risk assessments to protect sensitive information and maintain compliance
- Establishing regular training, reporting mechanisms, and internal audits to monitor data usage, track compliance, and prevent unauthorized access or misuse?
1:15 pm Lunch & Networking
1:45 pm Overcoming Data Ownership Challenges to Better Understand Roles & Responsibilities Within a Company While Ensuring Accountability
Synopsis
- Establishing ownership roles across departments to clarify accountability for data management, protection, and compliance
- Implementing policies, access controls, and data stewardship responsibilities to ensure transparency and compliance
- Encouraging collaboration between legal, IT, and compliance teams to align on responsibilities and address ownership gaps
2:15 pm Roundtable Discussion: The Importance of Bringing a Mindset Shift from ‘Compliance After Product Development’ to ‘Compliance During Product Development’ to Maximize Effective Cloud Compliance
Synopsis
- Embedding compliance practices from the outset of product development to prevent costly rework and ensure adherence to regulations
- Fostering close collaboration between development, quality assurance, and compliance teams for real-time feedback and alignment
- Ensuring ongoing compliance through integrated validation processes, audits, and automated checks throughout the development lifecycle
2:45 pm Demystifying Responsibilities When Moving from On-Premises to Cloud to Increase Visibility and Control Over Your Data
Synopsis
- Understanding the division of responsibilities between your organization and the cloud provider to ensure data security and compliance
- Defining roles, access controls, and compliance requirements to maintain visibility and control over data in the cloud
- Utilizing real-time monitoring, audit trails, and automated alerts to maintain oversight and ensure ongoing compliance with regulatory standards