FDA Discusses the Implications and Opportunities of CSA Draft Guidance on 21 CFR Part 11

Presented by: Joanne Goldberg, Senior Principal Quality Systems Specialist, Global IT Quality & Compliance, MedtronicKhaled Moussally, EVP Clients & Regulatory Relations, Compliance GroupFrancisco Vicenty, Program Manager, Case for Quality, U.S. FDADaniel Walter, Policy Analyst, U.S. FDA Since the release of the FDA draft on Computer Software Assurance (CSA), September 13th, 2022, many questions and concerns […]