Presented by: David W. Vincent MPH, Ph.D., CEO, VTI Life Sciences Dvelop-a-Compliant-Test-Method-Validation-David-Vincent-Lab-U-2022-SessionDownload
Presented by: Nathan Temple, Global Director C&Q, CAI Learn about key initiatives, industry drivers and trends that are transforming project delivery with a focus on operational readiness and speed to patient. Project delivery timelines continue to be scrutinized and there are powerful ways to shift validation off the critical path. More importantly, through Quality Risk […]
Presented by: Dori Gonzalez-Acevedo – CEO and co-founder at ProcellaRX & fellow Chief members:• Denise Dajles – Senior VP of R&D, Regulatory and Quality at Sientra• Catherine Hall – VP of Clinical Innovation and Quality at EndPoint Clinical• Elena Mack – VP, Global Manufacturing Quality, Olympus Corporation• Dinamarie Stefani – Head […]
Presented by: Mr. Vipul Doshi , Chief Quality & Compliance Officer at Zydus Lifesciences Limited This session is intended to help implement globally compliant automated process validation program in a pragmatic manner by following the principles of lifecycle based process validation guidance documents and current expectations for Pharmaceutical Quality Systems. This session will help in […]
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 […]
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