Understanding AI/ML in GMP: Validation, Risk and Real-World Application

Webinar: AI & Machine Learning in GMP – Hype, Reality, and Validation

Artificial Intelligence (AI) and Machine Learning (ML) are revolutionizing pharmaceutical manufacturing but how can these powerful technologies be implemented safely and compliantly in GxP-regulated environments?

In this free, 1-hour webinar, Dr. Ulrich Köllisch and Dr. Jennifer Roebber from GxP-CC GmbH will guide you through the opportunities and challenges of AI/ML in the life sciences sector. The session will be moderated by James Francum. Drawing from the latest ISPE GAMP guidance and current regulatory expectations from the EMA and FDA, this session provides practical insights into building compliant, future-ready AI/ML strategies.

Whether you’re just beginning to explore digital transformation or are already developing AI-based solutions, this webinar will help you navigate evolving requirements while embracing innovation with confidence.

What you’ll learn:

  • How AI and ML are applied in pharmaceutical processes

  • Key regulatory expectations and what inspectors look for

  • Validation strategies for both static and adaptive ML models

  • Important aspects of data integrity, algorithmic bias, and supplier oversight

  • Real-world examples, including Automated Visual Inspection and Large Language Models

Event Details:

Date: Thursday, July 10, 2025
Time: 4:00 p.m. (Berlin time)
Duration: 1 hour
Language: English

Click here to register: https://www.bigmarker.com/gxp-cc/understanding-ai-ml-in-gmp-validation-risk-and-real-worlds-application



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