2022 Agenda

12.00 EST | 9.00 PST Opening Remarks

12.05 EST | 9.05 PST Your Compliance and Technology Today

Synopsis

You have to know where you are to know where you are going. What systems are on-prem vs. cloud?
Where do you want to be?
• Understanding your organization’s compliance and technology maturity today – people, process, technology
• How ever-changing, global regulations impact your IT roadmap and how to create a sustainable strategy
• Considerations for harmonizing your regulated and non-regulated processes and data

12.40 EST | 9.40 PST Managing Your Regulated Cloud Technology

Synopsis

Regardless of where you are in your cloud journey, there are proven best practices to future-proof your cloud compliance strategy.
• Life sciences best practices for GxP cloud compliance
• Continuous compliance solutions
• Considerations for external support and a managed service approach

1.15 EST | 10.15 PST Break

1.25 EST | 10.25 PST FDA Perspectives on Cloud Technologies: An Update on the FDA’s Case for Quality & Its Computer Software Assurance Guidance

Synopsis

• FDA’s support of modern cloud technologies and automation
• CSA guidance update
• Case studies in CSA

2.00 EST | 11.00 PST Panel Discussion: Extracting Value From Your Cloud Data & Processes

Synopsis

An expert panel on innovative GxP use cases, monetizing your cloud data, and next-level GxP cloud compliance thinking
• Business opportunities and use cases for PaaS and IaaS qualification
• GxP process automation tools and best practices
• Making a case for artificial intelligence and machine learning
• Thoughts on how to monetize your data

2.55 EST | 11.55 PST Closing Remarks