Artificial Intelligence (AI) and Machine Learning (ML) are transforming pharmaceutical manufacturing - but how can these technologies be safely and effectively implemented in GxP environments?
Join Dr. Ulrich Köllisch and Dr. Jennifer Roebber from GxP-CC GmbH for a deep dive into the opportunities and challenges of AI/ML in GMP-regulated industries. This webinar explores real-world applications, the evolving regulatory landscape, and strategies for compliant validation based on the latest ISPE GAMP guidance. Whether you're just starting to explore AI/ML or already developing digital strategies, this session will equip you with the knowledge to navigate compliance while embracing innovation.
AGENDA
The fundamentals of AI/ML and their relevance to pharmaceutical processes
Key regulatory expectations from EMA and FDA
Validation strategies tailored for static and dynamic ML models
Critical considerations for data integrity, model bias, and supplier management
Use cases including Automated Visual Inspection and Large Language Models