Using Statistics as a Validation Risk Tool
Presented by: Raul Soto, Senior Principal Quality Engineer, Johnson & Johnson
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Presented by: Raul Soto, Senior Principal Quality Engineer, Johnson & Johnson
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, GSK Louie 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. FDA Since the release of the FDA draft on Computer Software Assurance (CSA), September […]
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 & […]
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