PDA Week

Andrew Chang and Steven Falcone, Novo Nordisk, discuss GMP mutual recognition, real-time digital monitoring, and the future of pharma QMS.

Andrew Chang and Steven Falcone, Novo Nordisk, share how real-time digital monitoring, smart sensors, and a globally connected manufacturing network are shaping pharma's QMS future.

Christopher Lewis, Umoja Biopharma, shares how AI is reshaping pharma through smarter oversight, personalized training, and actionable data insights.

Christopher Lewis, Umoja Biopharma, explores how AI is revolutionizing pharma training, predicting process issues, and unlocking the value of existing data.

Andrew Chang and Steven Falcone, Novo Nordisk, explain how FDA-EU GMP mutual recognition and a robust internal signal process drive global regulatory compliance.

Christopher Lewis, Umoja Biopharma, explores how AI can streamline compliance, cut investigation time, and free skilled workers for higher-value tasks

Susan Schniepp discusses how AI and digital twins speed up pharma batch release and detect data integrity issues while maintaining human oversight.

Susan Schniepp, Regulatory Compliance Associates Inc., explains how AI and digital twins speed up pharma batch release and detect data integrity issues with human oversight.

Susan Schniepp, Regulatory Compliance Associates Inc., discusses digital twins and AI in pharma, focusing on data integrity, human-in-the-loop roles, and evolving machine learning risks.

Susan Schniepp, Regulatory Compliance Associates Inc., shares strategies to streamline pharma quality, reduce costs via early detection, and use data to ensure safety.

Susan Schniepp, Regulatory Compliance Associates Inc., explains how flexibility, right-sized SOPs, and transparency keep compliance simple.

Michelle Dennis, MilliporeSigma, breaks down how biofluorescent particle counting and RFID traceability are improving speed, accuracy, and efficiency in pharma QC.

Susan Schniepp, Regulatory Compliance Associates Inc., discusses siloed pharma data being a hidden risk, with AI as a possible key to connecting quality systems and seeing the full manufacturing picture.

Susan Schniepp, Regulatory Compliance Associates Inc., says poor quality in pharma manufacturing is costly but catching defects early can saves millions.

Michelle Dennis at MilliporeSigma explores how biofluorescent particle counting and RFID traceability are transforming real-time environmental monitoring.

Richard Jaenisch explains how digitally interactive SOPs and Human-AI Training Parallelization help build, measure, and continuously improve AI-era workforce skills.

Ryan Murray, ValSource, breaks down far UVC technology, holistic contamination control strategies, and environmental monitoring in pharma manufacturing.

Malav Parikh, director, Quality Risk Management, Global Quality Compliance and Systems, Takeda, spoke with PharmTech about the technologies being used to fight counterfeiting and how predictive modeling can be used to validate transport conditions.

In regard to their presentations at PDA Week 2026, Richard Jaenisch and David Jaenisch discuss balancing AI integration with human expertise, compliance, and IP protection.