Progressive technology and compliance thinking to speed GxP cloud adoption and maturity
Data-driven companies leverage cloud-based solutions for GxP and non-GxP data to develop new business models in their bold pursuit of innovation. Hosted by USDM Life Sciences, this virtual event will help you apply Computer Software Assurance (CSA) guidance for a successful GxP cloud transformation, and senior leaders from regulated life sciences organizations will share ideas to advance your cloud compliance strategy wherever you are in your transformation.
Fill out the form to watch the video replay.
Event held on January 26, 2023.
What You'll Learn
- The latest on the FDA's Computer Software Assurance (CSA) draft guidance, including feedback from public comments and practical examples of ad-hoc and unscripted testing.
- A prescriptive approach for migrating and managing GxP cloud workloads to enable automation and more efficient GxP business processes.
- How an integrated approach to Quality and IT supports a continuously compliant tech stack.
- Real cloud-journey lessons learned from life sciences leaders, including how to get started, run pilots, and drive stakeholder alignment.
- How progressive technologies are creating new capabilities to advance drugs and devices.
Session 1: Computer Software Assurance Update
Hear directly from the FDA—get an update on the Computer Software Assurance (CSA) Draft Guidance.
- CSA update
- Feedback from November comments
- Practical examples of ad-hoc and unscripted testing
- Live Q&A
Panelists:
- Francisco Vicenty, Case for Quality Program Manager, FDA
- Ken Shitamoto, Senior Director IT, Gilead Sciences
- Stepheni Norton, Director of Product Management, USDM
Session 2: Automated GxP Cloud Compliance
Learn a prescriptive approach for migrating and managing your GxP cloud workloads to enable automation and create more efficient GxP business processes.
- An integrated approach to Quality and IT
- USDM framework for compliance to enable a continuously compliant tech stack
- Quality orchestration through automation
- Live Q&A
Panelists:
- Hovsep Kirikian, Director of Product Management, USDM
- Paula Dawson, Senior Program Manager, USDM
- David Blewitt, VP of Cloud Compliance, USDM
Session 3: GxP Cloud Journey Case Studies
Hear real stories from industry leaders going through their digital transformation journey and gain practical insight from their lessons learned.
- Cloud journey challenges
- Advice on getting started, pilot programs, and driving stakeholder alignment
- Early business results and positive outcomes
- Q&A
Panelists:
- John Savage, Senior Director, Information Technology & Research & Development, Turning Point Therapeutics (a Bristol Myers Squibb company)
- Simon Zelazo, Senior Director, Head of IT and Informatics, Selecta Biosciences
- Mei Jiang, Director R&D Applications, Mersana Therapeutics
- Additional panelists to-be-confirmed
Session 4: New Capabilities with Progressive Technology
Listen to an expert panel of life sciences technology leaders share how their companies focus on solving life sciences challenges to advance drugs and devices.
- Google Cloud’s next-level data processing power
- ServiceNow’s Healthcare and Life Sciences Services Management platform
- ThingWorx/PTC IoT innovation
- Vuforia/PTC augmented reality and virtual reality solutions
- Live Q&A
Panelists:
- Shweta Maniar, Director, Healthcare & Life Sciences Solutions, Google Cloud
- Jon Cohen, Head of Life Sciences Industry Go-To-Market – Americas, ServiceNow
- Rene Zoelfl, Global Industry Advisor Life Sciences, PTC
- Ryan Orwoll, VP of Product Management, PTC, Vuforia Augmented Reality Team
USDM's point of view: Cloud adoption in GxP environments stalls when compliance is treated as a one-time gate instead of a continuous, automated capability. The FDA's Computer Software Assurance approach lets teams focus testing effort where patient and product risk actually lives, and USDM pairs that risk-based mindset with an integrated Quality-and-IT framework so your tech stack stays compliant as it changes. The result is faster cloud transformation without trading away the controls that regulated life sciences work demands. Explore how this becomes an ongoing program with USDM Cloud Assurance.
Why Watch:
Simplify, automate, and optimize your GxP technologies and business processes. The event will begin with an update from the U.S. Food and Drug Administration (FDA) on the CSA draft guidance, then USDM subject matter experts will share a prescriptive approach to advance quality through automation. You’ll hear cloud-journey lessons learned from real customers, and a panel of technology leaders will share novel technologies driving transformative capabilities.
Who Should Watch:
Industry / Company Type
- Pharma
- BioPharma
- Biotechnology
- Medical Device
- CRO / CMO
- Any regulated life sciences organization
Relevant Roles / Job Titles
IT Titles
- Chief Information Officer (CIO) / Chief Technology Officer (CTO) / Chief Systems Office (CSO)
- Head of Cloud Infrastructure & Cybersecurity Security
- VP of IT / Director of IT / Associate Director of IT / Manager of IT
- VP/Director of IT Infrastructure
- Director/Manager of GxP Applications
- Director/Manager of R&D Applications
- Cloud Architects/Cloud Developers
- Cloud Engineer / Computer Systems Validation Engineer / Validation Engineer
Quality Titles
- Chief Compliance Officer (Healthcare)
- Head of Quality Assurance
- VP/Director/Manager of Quality Assurance (QA)
- Systems Compliance, QA Regulatory Affairs
- VP/Director of Quality Engineering
- VP/Director of Document Control
Regulatory Titles
- Head/VP/Director/Manager of Regulatory Affairs
- Head/VP/Director/Manager Regulatory Operations
- Head/VP/Director/Manager of Compliance
Relevant Titles
- VP/Director/Manager of Clinical Operations
- VP/Director/Manager of Translational Research
- VP/Director/Manager R&D
- VP/Director/Manager of Research Operations
- VP/Director/Manager Labs
Frequently Asked Questions
What is Computer Software Assurance (CSA)?
Computer Software Assurance is a risk-based approach to assuring that software used in regulated environments is fit for its intended use, focusing testing effort where it matters most. This summit opened with an FDA update on the CSA draft guidance, including feedback from public comments and practical examples of ad-hoc and unscripted testing. Learn more on our Computer Software Assurance (CSA) overview.
How does CSA relate to data integrity and 21 CFR Part 11?
A risk-based assurance approach is part of a broader compliance picture that includes data integrity and 21 CFR Part 11 expectations for electronic records and signatures. The summit's sessions on automated GxP cloud compliance and a continuously compliant tech stack speak directly to keeping these controls intact as systems move to the cloud.
What does "automated GxP cloud compliance" mean?
It means migrating and managing GxP cloud workloads using an integrated approach to Quality and IT, with a framework that keeps the tech stack continuously compliant rather than compliant only at a point in time. Session 2 covered USDM's prescriptive approach to quality orchestration through automation, which is delivered as an ongoing program through USDM Cloud Assurance.
Who should watch this summit?
The summit is built for IT, Quality, Regulatory, and R&D leaders at pharma, biopharma, biotechnology, medical device, and CRO/CMO organizations—anyone in a regulated life sciences organization driving cloud and GxP transformation.
How can I watch the on-demand replay?
Fill out the form on this page to watch the video replay of all four sessions on demand. If you'd like to discuss applying CSA and automated cloud compliance to your own transformation, contact us.
Watch on demand: Fill out the form on this page to access the full replay of all four summit sessions, including the FDA CSA update and the customer cloud-journey case studies. Ready to map this to your own GxP cloud transformation? Talk to a USDM expert about a continuously compliant cloud strategy.
Please email usdm@usdm.com with any questions.