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 […]
Presented by Loganathan Kumarasamy • Understanding the current landscape of AI and ML• Where do we stand with the regulations?• Current happenings in the regulatory space and what can we expect in the next few years• Good Machine Learning Practices – Key things that we should consider during software development• Practical take away on GMLPTakeaway […]
Presented by Raul Soto Testing is a critical element in software validation. Effective testing allows us to provide documented evidence that our computerized system is fit for use as per its requirements / use cases. But how do we optimize / streamline testing to make it more effective?• Testing fundamentalso Elements of a successful test […]
Presented by Ken Shitamoto Recently, people have begun to replace “risk-based” with “critical thinking and risk-based” without defining what it means to think critically.• Disambiguate the phrase• Provide pragmatic guidance in the context of CSA• Receive the tools necessary to drive process improvement forward critical thinking on critical thinkingDownload
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