Future-Proofing CGT Manufacturing: Integrating Digital Solutions With Regulatory Readiness
Access the video by filling out the form.
Key Takeaways
Regulatory strategies for global consistency: How to harmonize compliance across FDA and EMA requirements while using connected digital tools to turn regulatory demands into competitive advantages and innovation accelerators
Overcoming cGMP complexity at scale: Practical approaches to managing the unique challenges of autologous and allogeneic manufacturing, from embedding quality at the source to minimizing deviations in batch-of-one environments
Digital transformation wins for CGT: Where to start your paperless journey, how to break down cultural barriers to digital adoption, and which technologies deliver the most immediate impact on quality testing, process consistency, and release times
Future-proofing your CGT operations: What digitally mature CGT manufacturing looks like in practice, and how emerging technologies like AI, real-time analytics, and modular facilities will reshape the industry over the next five years
About This Event
Join MasterControl and Life Science Connect for an essential discussion on the evolving landscape of cell and gene therapy (CGT) manufacturing. This expert panel will explore how leading CGT manufacturers are addressing critical challenges across regulatory compliance, cGMP execution, and digital transformation. As the industry scales from personalized, autologous therapies to broader commercial production, organizations face unique pressures to maintain quality, ensure traceability, and meet evolving regulatory expectations across global markets—all while accelerating patient access to life-saving treatments.
Our panelists will share practical insights on transforming regulatory requirements from barriers into innovation drivers, embedding quality at the source in complex manufacturing environments, and leveraging digital tools to create real-time visibility and connected compliance. Whether you're navigating FDA and EMA harmonization, scaling batch-of-one production, or planning your digital roadmap, this webinar will provide actionable strategies to help your organization build more resilient, efficient, and future-ready CGT operations.
Key Takeaways
Regulatory strategies for global consistency: How to harmonize compliance across FDA and EMA requirements while using connected digital tools to turn regulatory demands into competitive advantages and innovation accelerators
Overcoming cGMP complexity at scale: Practical approaches to managing the unique challenges of autologous and allogeneic manufacturing, from embedding quality at the source to minimizing deviations in batch-of-one environments
Digital transformation wins for CGT: Where to start your paperless journey, how to break down cultural barriers to digital adoption, and which technologies deliver the most immediate impact on quality testing, process consistency, and release times
Future-proofing your CGT operations: What digitally mature CGT manufacturing looks like in practice, and how emerging technologies like AI, real-time analytics, and modular facilities will reshape the industry over the next five years
Michelle Janas
Regional Account Executive
MasterControl
Michelle has more than thirteen years’ experience in Biologics, API, Medical Device and Pharmaceuticals working various functions from Global Quality Assurance to Operational Excellence in both Quality and Manufacturing. From releasing production records to becoming a Global GxP & eCompliance Director, and a variety of roles in manufacturing quality, Michelle has implemented software to multiple manufacturing sites all over the globe.