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.
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Event held on January 26, 2023.
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Hear directly from the FDA—get an update on the Computer Software Assurance (CSA) Draft Guidance.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
- 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
- John Petrakis, VP of Cloud Assurance, USDM
- 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
- 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
- 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
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
- Medical Device
- CRO / CMO
- Any regulated life sciences organization
Relevant Roles / Job Titles
- Chief Information Officer (CIO) / Chief Technology Officer (CTO) / Chief Systems Office (CSO)
- Head of Cloud Infrastructure & Cyber 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
- 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
- Head/VP/Director/Manager of Regulatory Affairs
- Head/VP/Director/Manager Regulatory Operations
- Head/VP/Director/Manager of Compliance
- 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
Please email firstname.lastname@example.org with any questions.