This online webinar will be given via Zoom.

Presented by: Bhasker Sambar, Alvogen Inc.

Webinar Category: Regulatory

Regulatory Area of Interest: GMP

Description:

The pharmaceutical industry is rapidly evolving toward Pharma 4.0, where artificial intelligence (AI), digital twins, predictive analytics, and real-time process monitoring are transforming how drug products are developed and manufactured. This webinar will introduce the concept of digital twins in pharmaceutical manufacturing and explain how virtual process models can improve product quality, manufacturing efficiency, deviation reduction, and regulatory compliance.

The session will provide practical examples from sterile injectables, suspension products, and continuous manufacturing environments, highlighting how digital twins can support process optimization, scale-up, root cause investigations, and commercial manufacturing reliability. Attendees will also gain insight into FDA expectations, data integrity considerations, GMP implications, and future opportunities for AI-enabled autonomous pharmaceutical manufacturing.

This webinar is intended for pharmaceutical professionals working in Quality Assurance, Manufacturing, Process Development, Regulatory Affairs, Validation, and Pharmaceutical R&D who are interested in understanding the future of smart manufacturing and digital transformation in the pharmaceutical industry.

RQAP Re-registration units approved: TBD