Compliance establishment and maintenance is complex, and it’s critical to have a partner that has both the regulatory expertise and the technology expertise
SANTA BARBARA, Calif. (PRWEB) March 18, 2019
For more than 15 years, USDM Life Sciences and Oracle have partnered together to develop solutions that allow life science companies to easily comply with FDA 21 CFR Part 11 and EMA EudraLex Volume 4 Annex 11 regulatory requirements. USDM’s Cloud Assurance™ is a managed service delivering end-to-end GxP compliance from vendor audit through ongoing validation maintenance, including every new release. Cloud Assurance provides Oracle Fusion SaaS customers a harmonized, continuous compliance experience.
What: Best Practices for Managing GxP Compliance in the Oracle Cloud
When: Thursday, March 21, 2:50-3:40 PM PT / South Pacific B - North Convention Center
Where: Oracle Modern Business Experience — Mandalay Bay Convention Center — Las Vegas, NV
Who: David Blewitt, Vice President of Cloud Compliance at USDM Life Sciences and Todd Hein, Executive Director of Life Sciences at Oracle
USDM Life Sciences will also have an exhibit located in the PLM section (booth #5).
“Compliance establishment and maintenance is complex, and it’s critical to have a partner that has both the regulatory expertise and the technology expertise,” said David Blewitt, Vice President of Cloud Compliance at USDM Life Sciences. “USDM and Oracle work together to deliver a comprehensive GxP solution so Oracle customers can focus on innovation.”
David Blewitt is the Vice President of Cloud Compliance at USDM Life Sciences. David is an accomplished life sciences regulatory and IS compliance professional with extensive hands-on and leadership experience in the pharmaceutical, medical device, biotech, and blood management industries. He is a highly regarded expert on a wide range of regulatory predicate rules.
Oracle Modern Business Experience is March 19-21, 2019 in Las Vegas, Nevada.
About USDM Life Sciences:
USDM Life Sciences provides strategy and compliant technology solutions to regulated life sciences companies and makes it easy to accelerate transformation and innovation. USDM Life Sciences focuses exclusively on the regulated biotechnology, pharmaceutical, and medical device industries and is a compliance partner with the world’s top technology software developers. For more information, visit http://www.usdm.com
USDM Life Sciences