About Event
Welcome to the 4th GxP Cloud Compliance Summit
Join over 100 Life Science IT & Quality professionals at the GxP Cloud Compliance Summit. Gain real-life insights from regulatory, security, and quality experts as they share case studies of successful and challenging cloud migrations. This definitive conference supports life science companies in implementing a practical roadmap for GxP-regulated applications and secure cloud hosting of health data. Ensure compliance with ease and minimize risks during migration. Don't miss this opportunity to network and enhance your knowledge in the industry.
Agenda highlights
Applying GAMP® 5 guidance on critical thinking to your engineering and compliance activities, understanding what it really means and how to plan, perform and report it through system and data lifecycles
Learning to leverage the CSA approach to compliance; understanding the work required to properly implement CSA and selecting tools to support the process with Ultragenyx Pharmaceutical, Arcutis Biotherapeutics & Johnson & Johnson
Streamlining strategies for maintaining data privacy when hosting health data in the cloud to comply with privacy, regulatory, and 3rd party agreements with Sema4 – geneDx, Sana Biotechnology, and Genmab
Implementing plans, key controls, and workflows
for lightweight GxP content management systems and leveraging GxP cloud system change control tactics to remain compliant
with INCOG Biopharma Services and Schrödinger
Best practices for implementing a lifecycle of risk
management approach to the cloud, including
living risk assessments and Q9 R1 guidance, to protect product
quality and patient data with Amylyx Pharmaceuticals
What Previous Attendees Say:
“Excellent forum to understand GxP compliance, challenges and solutions!”
Medtronic
“The GxP Cloud Compliance summit was informative for both experienced compliance professionals and those new to the area, and provided valuable networking activities with industry peers”
TraceLink