*All Times Shown are in Eastern Daylight Time*

9:00 am Virtual Registration & Networking

9:25 am Opening Remarks from the Chair

  • David Blewitt Vice President, Cloud Compliance , USDM Life Sciences

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 Becoming Regulated Cloud Native on AWS

10:30 am Accelerate Product Development with a Unified, Validation-Ready Benchling Solution

Synopsis

• As life science companies advance their products through the R&D lifecycle, the focus gradually moves from hypothesis-driven research to more controlled, structured development that falls under the scope of regulatory compliance and validation.
• Often this drives companies to use disparate IT solutions, making it increasingly difficult for Research and Development teams to collaborate across phases.
• In this presentation, learn how New England Biolabs leverages Benchling’s unified, validation-ready solution to improve tech transfer, reduce validation time, generate meaningful insights, and enable faster assembly of data packages.

11:00 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

11:30 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!

12:15 pm 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

12:45 pm Panel Discussion: Reimagine GxP Workloads in the Cloud

Synopsis

  • Process innovation in your cloud adoption journey
  • Compliant platform needs and considerations
  • Improving performance to drive better business results

1:30 pm Virtual Exhibition Hall Break

Synopsis

Use this opportunity to visit our Partners’ Virtual Booths to explore exciting platforms enabling compliant GxP cloud migration and potentially meet your next partner!

Due Diligence for GxP Cloud Deployment & Implementation

2:30 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

3:00 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

3:30 pm GxP System Integration

  • Cory Brown Head of IT and 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

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