Workshop “Digital Transformation and GAMP: Implementing an AI Solution in a Pharma 4.0 Context”
Integrating innovative AI solutions serves as a cornerstone in the transition toward data-driven organizations and digital transformation. At the same time, ensuring patient safety, maintaining, and achieving regulatory compliance remain priorities within GxP-regulated areas. Examples of Pharma 4.0 principles and GAMP® concepts help in achieving these goals, where specific maturity assessments and risk management techniques have been established for application in an AI context.
This interactive workshop delves into practical aspects of implementing AI in a GxP-regulated environment, guided by the principles and guidance established in ISPE Pharma 4.0® and GAMP®. Participants will explore maturity assessment techniques to evaluate organizational readiness for digital transformation, focusing on critical factors such as infrastructure, culture, and existing processes. They will also have the chance to explore a comprehensive risk assessment methodology tailored to AI solutions, focusing on methods for identifying and mitigating risks to patient safety, data integrity, and product quality.
Through real-world examples and hands-on exercises, attendees will gain actionable insights into aligning AI implementation with digitization objectives while fulfilling quality expectations and adhering to regulatory requirements.
Integrating innovative AI solutions serves as a cornerstone in the transition toward data-driven organizations and digital transformation. At the same time, ensuring patient safety, maintaining, and achieving regulatory compliance remain priorities within GxP-regulated areas. Examples of Pharma 4.0 principles and GAMP® concepts help in achieving these goals, where specific maturity assessments and risk management techniques have been established for application in an AI context.
This interactive workshop delves into practical aspects of implementing AI in a GxP-regulated environment, guided by the principles and guidance established in ISPE Pharma 4.0® and GAMP®. Participants will explore maturity assessment techniques to evaluate organizational readiness for digital transformation, focusing on critical factors such as infrastructure, culture, and existing processes. They will also have the chance to explore a comprehensive risk assessment methodology tailored to AI solutions, focusing on methods for identifying and mitigating risks to patient safety, data integrity, and product quality.
Through real-world examples and hands-on exercises, attendees will gain actionable insights into aligning AI implementation with digitization objectives while fulfilling quality expectations and adhering to regulatory requirements.
Session type
Schedule
Name
Workshop: Digital Transformation and GAMP
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