Conference Day One
Wednesday, July 16, 2025
8:10 am Check In & Light Breakfast
8:50 am Chair’s Opening Remarks
Qualifying Cloud Compliance to Ensure Streamlined Application Across Internal & External Stakeholders
9:00 am Extracting & Centralizing Regulations to Seamlessly Integrate them into Internal Processes
Synopsis
- Identifying and extracting key compliance requirements
- Streamlining regulations into a unified internal system
- Embedding compliance into workflows for efficiency and accuracy
9:30 am Applying FDA 21 CFR Part 11 Guidance When Qualifying Compliance of External Cloud Providers
Synopsis
- Key requirements for electronic records and signatures in regulated cloud environments
- Assessing audit trails, access controls, and validation processes to ensure adherence
- Strategies for verifying cloud vendors meet regulatory expectations and maintain data integrity
10:00 am Roundtable Discussion: Monitoring External Cloud Providers to Ensure Their Quality Management Systems are Compliant
Synopsis
- Establishing clear criteria for GxP-aligned Quality Management Systems
- Implementing risk-based oversight, periodic audits, and real-time compliance tracking
- Enforcing service level agreements, documentation reviews, and fostering proactive communication with providers
10:30 am Speed Networking
Synopsis
This session is a great opportunity to introduce yourself to the attendees that you would like to have more in depth conversations with. This session is the ideal opportunity to get face-to-face time with experts in IT, CSV, Quality, Compliance and more to establish meaningful business relationships.
11:00 am Morning Break
11:30 am Collaborating with Cloud Vendors to Bridge the Gap Between Technical Expertise & Compliance
Synopsis
- Establishing clear compliance requirements and validation processes from the start
- Educating cloud vendors on GxP standards to ensure technical solutions meet regulatory needs
- Implementing regular audits, documentation reviews, and open communication to maintain trust and adherence
12:00 pm Panel Discussion: Empowering Teams with AI Literacy to Safeguard Data & Maintain GxP Standards & Data Integrity
Synopsis
- Educating teams on responsible AI use while aligning with GxP compliance
- Implementing policies to prevent unauthorized AI usage and protect sensitive data
- Leveraging AI for efficiency while ensuring adherence to GxP standards and data integrity
12:30 pm Lunch & Networking
1:30 pm Optimizing Disaster Recovery Plans to Ensure Seamless Management of Internal Processes
Synopsis
- Ensuring data integrity, system validation, and regulatory adherence in recovery strategies
- Implementing failover systems, backup redundancy, and real-time recovery testing
- Regularly updating disaster recovery plans through audits, simulations, and risk assessments
2:00 pm Roundtable Discussion: Breeding Confidence When Moving Away from In- House to the Cloud Across Businesses
Synopsis
- Ensuring robust governance, security protocols, and GxP standards to assure stakeholders during the transition.
- Implementing a phased approach, risk assessments, and change management strategies to minimize disruption and ensure data integrity.
- Providing ongoing training, regular audits, and clear communication to reinforce confidence in cloud systems post-migration.
2:30 pm Afternoon Break & Poster Session
Synopsis
Witness some of the latest and greatest research in the cloud compliance field by Pharma, Biotech, Medical Device Developers, and LS Service Providers in this spotlight poster session!. *Please visit the website for the T&Cs for presenting a poster
Maximizing Security Frameworks to Ensure Safety of Data
3:00 pm Optimizing Data Security Across Different Stages from On-Premises, In- Transit, to In-Cloud
Synopsis
- Implementing access controls, encryption, and robust authentication to protect local environments
- Utilizing secure protocols, end-to-end encryption, and real-time monitoring to prevent breaches
- Applying continuous compliance checks, multi-layered security, and vendor risk assessments to maintain regulatory adherence
3:30 pm Roundtable Discussion: Mitigating Risks Posed by Multi-Tenant Cloud Environments Through Management Strategies Ensuring Real-Time Audits
Synopsis
- Identifying security, data integrity, and access control challenges in shared cloud environments
- Leveraging encryption, access controls, and segregation strategies to protect sensitive data
- Using automated monitoring, periodic assessments, and vendor oversight to ensure ongoing GxP adherence
4:00 pm Optimizing Methodologies to Ensure Data Remains Accurate & Accessible in Shared Environments
Synopsis
- Defining roles and permissions in shared environments to ensure only authorized users can access and modify critical data
- Using automated validation, audit trails, and version control systems to ensure data accuracy and consistency across all users
- Strategies to optimize data sharing and retrieval in cloud-based environments without compromising security or compliance