In order to achieve cGxP compliance in a complex, regulated cloud environment, specific elements need to be in place: (1) establishing a robust, meaningful SLA with the vendor, (2) Risk-Based Validation activities to leverage supplier activity, and (3) maintenance of the compliant state.
USDM Life Sciences and Oracle work together to deliver a comprehensive compliance solution for initial and ongoing maintenance of Oracle Cloud. USDM’s Cloud Assurance solution saves Oracle customers a significant amount of time, reduces compliance costs, and provides an efficient change management process for quarterly updates. Learn how USDM’s Cloud Assurance managed service mitigates risk and delivers continuous compliance for Oracle Cloud customers.
The presentation will include:
- Steps in achieving Oracle cGxP cloud validation
- How Oracle Cloud customers leverage USDM’s audits
- Compliance risk management in the Cloud
- Maintaining compliance in the ever-changing cloud
- How a regulated Biotech company implemented and validated Oracle SCM/MFG using USDM Cloud Assurance
- Live Q & A session
About the Presenters:
Vice President of Cloud Compliance David is an accomplished life science regulatory and IS compliance professional with extensive hands-on and leadership experience in the pharmaceutical, medical device, biotech and blood management industries. He is an acknowledged expert on a wide range of regulatory predicate rules.
Executive Director of Life Sciences at Oracle As the Sr. Director of Life Sciences, Todd focuses exclusively on supporting Oracle customers in the medical biopharma and medical device industries. His responsibilities include identifying common business challenges the industry is facing and defining best practices to address these through existing Oracle applications, on-going product development, and partner eco-system support.