Presented by: Jeff Ramos, Solutions Engineer, ValGenesisChange is the only permanent thing in this world. However, in Life Sciences, adapting to new norms may be slow and can lead to apprehension. Join us in this webinar to learn how you can mitigate those fears and take a path forward to adapt CSA in your workplace.Benefits:Gain […]
Presented by: Roque Redondo, Sr. Technical Consultant, Mentor Technical Group
Presented by: Philip Jarvis, Director C&Q and Digital Validation Strategy, VEQTORHow digital validation tools are enabling validation 4.0Risk based data integrity processes (importance of data mapping and criticality of data) Building in Data integrity by design into digital validation systems Data integrity guidance watchouts – Bring paper into the digital world compliantly and defining “true […]
Presented by:Stephen Cook, Sr. Director – Governance & Operational Excellence, GSKLouie Rayal, Vice President, Governance, Risk and Compliance, GSK Marc Koetter, Senior Manager Computer System Validation & IT Governance, Fresenius Medical Care Cisco Vicenty, Case for Quality Program Manager, U.S. FDASince the release of the FDA draft on Computer Software Assurance (CSA), September 13th, 2022, […]
Presented by:Calvin Kim, Head of Quality Systems and Validation, Samsung Biologics Suju Hwang, Senior Manager, Digital Quality & Compliance, Samsung Biologics• Gain insight on how key strategy & framework are established in consideration of risk-based approach in CSA and Part 11 requirements• Understand the importance of aligning R&R across CSV relevant processes & stakeholders• Determine […]
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