Category: CSV/CSA

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Computer Software Assurance (CSA) Implementation with Focus on Industry Case Study

Presented by: Linda Lagrou, Senior Manager IT Quality, Abbott LaboratoriesGaurav Walia, Senior Global Director and Sr. Associate Partner, PQE Group •    Demonstration of CSA practical execution•    Real world highlights of CSA implementation case study•    Use of critical thinking with the implementation•    Use of automation tools with the CSA Approach•    Overarching […]

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CSV – Effective System Level Risk Assessment

Presented By: Rohit Tyagi, President, SAGAX Team Key Highlights: Regulatory Compliance: How implementing robust CSV processes is essential for pharmaceutical companies to ensure product quality and patient safety, while remaining compliant with regulations. Risk Identification: Learn how to properly assess risk in using a computerized system focusing on patient safety. Data Integrity Assurance: Identifying potential […]

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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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