Ponente: Ryan Basdeo, SAGE Engineering Services Ltd
Artificial Intelligence (AI) in sterile manufacturing for Visual Inspection (VI) represents a critical regulatory challenge, given that the 100% visual inspection of parenteral drug products is an importantquality assurance step mandated by global pharmacopeias and GMP guidelines to ensure product quality and patient safety.
AI, particularly deep learning, overcomes the key limitations of traditional inspection, such as high false rejection rates and an inability to adapt to new contaminants.
By learning complex visual patterns, AI systems enable higher detection accuracy and enhanced consistency.
- Ensuring training data is fit for purpose to mitigate bias and support reliable performance.
- Applying Explainable AI (XAI) to enable transparency and human oversight in decision-making.
- Managing model changes throughout the validated life cycle to maintain regulatory compliance.
Ryan Basdeo
Co-Owner and Principal
SAGE Engineering Services Ltd
Co-Owner and Principal at SAGE Engineering Services Ltd. with over 15 years of experience in pharmaceutical engineering and automated visual inspection systems.
He has led global projects in sterile manufacturing, machine vision, and GMP-compliant system implementation.
