CSV/CSA - Kenx Members

Category: CSV/CSA

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Customize Validation & GxP Knowledge on Demand – Using ChaptGPT in Enterprise Deployments

Presented By: Nick Armstrong, Sr. Director, Digital Enablement, CAI • Introduction to generative AI and large language models, benefits and drawbacks• Concepts of word embedding and vectoring to reduce costs of generative AI• Customizing knowledge bases for use in generative AI to ensure up to date information while protecting your proprietary information• Guard railing and […]

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Using and Qualifying ChatGPT – Compliantly Harness the Power of AI-Powered Platforms in Validation Processes

Presented by: Steve Thompson, Sr. Director Product Marketing, ValGenesis, Inc. · Understand why ChatGPT (cGPT) and Generative AI has changed our world · The pros and cons of Artificial Intelligence and Machine Learning (which encapsulates GPT) Use Cases for cGPT in Validation: How to use cGPT When to use, when not to use Potential interfaces […]

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Automating CSA Risk Management: Perspectives from BD

Presented by: Frank Meledandri Sr., Associate Director, Quality Strategy Quality Management, BDRoy Devine, GPO Computer System Validation, BD Moderator:Jason Spiegler, SVP of Strategy, Sales, and Marketing, Compliance Group BD’s Roy Devine and Frank Meledandri Sr will share their experiences in driving a risk-based CSA methodology. In addition to touching on procedural and cultural change, they […]

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Automation in Process Validation: A Case Study

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 […]

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FDA Discusses the Implications and Opportunities of CSA Draft Guidance on 21 CFR Part 11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

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