*All Times Shown are in Eastern Daylight Time*

9:00 am Virtual Registration & Networking

9:25 am Opening Remarks from the Chair

Enhancing Regulatory Compliance & Computer Systems Validation

9:30 am Regulatory Compliance & Risk Considerations for Cloud Computing

  • Laur Oltean Senior Computer Systems Validation Specialist, Engineering, IT , Lonza

Synopsis

• Finding the least burdensome approach to satisfy computerized system validation requirements
• Evaluating data integrity best practices
• Outlining good documentation practice and identifying common mistakes

10:00 am Best Practice for Regulation of Cloud Systems for the FDA

  • Victor Huynh Executive Director, Information Security & Risk Management, AbbVie

Synopsis

• Exploring CFR 21 part 11: What does it mean to your GxP environment?
• Identifying the critical requirements
• Suggestions on how to remain compliant

10:30 am Becoming Regulated Cloud Native on AWS

11:00 am Morning Speed Networking

Synopsis

Connect with your industry peers through our virtual speed networking tool. You will be paired up with a fellow colleague for a 5 minute ice breaking conversation!

11:30 am HIPAA, Part 11 and GxP – Protecting Patient Health Information in the Cloud

  • Les Jordan Chief Product & Strategy Officer , MobileSmith Health

Synopsis

  • Understanding how and where these regulations intersect for organizations that support both research and patient health
  • Addressing technical challenges across these regulations
  • Managing policy and procedure documents to keep up to date with current compliance regulations

12:00 pm Panel Discussion: Reimagine GxP Workloads in the Cloud

Synopsis

• GxP use cases and phases in your public cloud adoption journey
• Considerations for qualifying your infrastructure
• Achieving a continuously compliant tech-stack

12:30 pm Lunch Break | 1-2-1 Meetings

Synopsis

Grab a bite while joining our virtual lunch chat room, or use this opportunity to visit our Partners’ Virtual Booths

Due Diligence for GxP Cloud Deployment & Implementation

1:30 pm Case Study – Working with Real World Evidence Data in the Cloud

Synopsis

• FDA data quality requirements for RWE data in a cloud environment to support FDA PMA/510(K) submissions for Laboratory Developed Tests Risk-based approach for navigating FDA cybersecurity and GxP/Part 11 requirements
• Addressing privacy requirements when working with global multinational Life Sciences companies

2:00 pm Lean GxP: Streamlining GxP for Enterprise Software Startups

Synopsis

• Adapting your QMS to existing processes with a focus on SDLC and risk management
• Reducing documentation burden through automation and by embedding it into the codebase
• Leverage low-maintenance system architecture such as serverless computing and database systems

2:30 pm Afternoon Networking Break | 1-2-1 Meetings

Synopsis

Take this opportunity to meet with our expert partners for 1-2-1 meetings to find out about their latest innovations.

3:00 pm GxP System Integration

  • Cory Brown Senior Director, IT & Head of GxP Digital, Tmunity Therapeutics Inc.

Synopsis

• Aligning GxP and ensuring communication between information systems
• Requirements for compliant IT infrastructure and architecture
• Use of LIMS to ensure GxP Compliance

3:30 pm Fireside Chat: GxP Data Migration – What Should You Consider

  • Rimesh Gor Associate Director, IT Business Relationship Management , Orchard Therapeutics

Synopsis

• Pre-project initiation discussion and how to identify the best platform
• Considerations for using the cloud in GxP environments and change management strategies
• Common pitfalls and note what aspects require additional vigilance with when moving to the cloud

4:00 pm Chair’s Closing Remarks & End of Day 1