*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
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
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 Approaching the Health Insurance Portability & Accountability Act 1996 (HIPPA)
Synopsis
• Understanding the HIPPA Privacy Rule
• Defining access, auditing and data integrity controls to overcome technical challenges
• Determining how to manage policy and procedure documents to keep up to date with current compliance regulations
12:00 pm Panel Discussion: Managing GxP Workloads in the Public 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
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
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