iCPV™

ValGenesis iClean™ transforms cleaning validation by digitizing and automating workflows, reducing documentation cycle times, ensuring compliance, and enhancing execution efficiency, helping you bring products to market faster while maintaining the highest quality standards.

ValGenesis iCMC™ can be your superpower. It’s designed to simplify how you apply QbD frameworks to your process and analytical method development.The result? More robust manufacturing processes - and faster time to market.

In this talk we explore the role of AI and ML in modernizing manufacturing, particularly in pharma and biotech. Despite the immense potential, the industry is still transitioning from traditional processes to digitalization, overcoming hurdles like regulatory compliance, cultural shifts, fulfilment of gaps in skill set and data infrastructure limitations. AI-driven analytics enhance product knowledge through its lifecycle, from process development using Quality by Design (QbD) to process validation and Continued Process Verification (CPV) in a holistic approach that ensures consistent process robustness, continuous improvement and product quality. Another example is the use of large language models applied during process validation with massive cost and time gains in generating error free validation documentation. Finally, a Case Study for an oral dosage form showcases a real-world implementation of a digital twin demonstrating AI’s role in process control, integrating real-time data analysis and predictive modelling.

Margarida Ventura (Senior Consultant) will present the webinar Revolutionizing CMC in Drug Development: How to Reduce Errors and Delays in Quality by Design on May 28 at 8:00 AM and 12:00 PM EDT.

Learn how to avoid common QbD pitfalls like inconsistent risk assessments, fragmented data, and poor collaboration. Discover digital tools and case studies that show how integrated platforms enhance CMC success.

Register to gain strategies for effective, sustainable QbD—live or on-demand via recording.