Presented by: Raul Soto, Senior Principal Quality Engineer, Johnson & Johnson To access this post, you must purchase MEMBER PLUS + or MEMBER PLUS 6M FREE.
Presented by: Roque Redondo, Sr. Technical Consultant, Mentor Technical Group
Presented by:Laura Pack, Senior Director, Quality Control and Statistics, Rezolute, Inc.Kenneth Miller, Director, Global Stability and CMC Analytical Data Management, BioMarin Pharmaceutical, Inc.Watch a panel of analytical experts discuss the current hot topics, issues, and industry practices of the Analytical Laboratory.
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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