Exclusive Breakfast Workshops

Wednesday, December 11

7:45 am – 9:45 am Workshop A

Balancing Automation & Human Intervention in Continuous Processing for Optimal Efficiency

Synopsis

Optimizing automation and human intervention in continuous processing is crucial to enhance efficiency, maintain product quality, and ensure that advanced technologies are effectively integrated into existing workflows, empowering personnel with the necessary skills to manage and adapt to evolving production demands.

Attend this session to:

  • Examine the technical aspects of integrating advanced automation systems into existing workflows, including compatibility and interoperability challenges
  • Identify the necessary skills and training required for personnel to manage and collaborate with automated systems effectively
  • Utilize real-time data and analytics from automated systems to inform decision-making processes and improve process control
  • Implement sophisticated error detection and correction mechanisms within automated systems to minimize downtime and maintain product quality
  • Analyze how automation can be scaled and adapted to accommodate changes in production demands while ensuring consistency and efficiency

Thursday, December 12

7:45 am – 9:45 am Workshop B

Navigating Regulatory and Compliance Challenges in PAT Implementation

  • Nidhi Kotecha Program Director, Gates Biomanufacturing Facility

Synopsis

Navigating regulatory and compliance challenges in PAT implementation is essential for ensuring that secure and reliable data management practices meet stringent standards, enabling the effective use of advanced tools for real-time monitoring and decision-making while maintaining adherence to GMP requirements.

Attend this session to:

  • Implement strategies for secure and reliable data capture, storage and retrieval to meet regulatory standards, ensuring all electronic records are trustworthy and auditable
  • Develop effective methodologies for data collection, preprocessing and quality assurance, providing reliable and accurate inputs for machine learning models to enhance decision-making processes
  • Utilize advanced PAT tools for real-time compliance testing and monitoring, reducing lead times, minimizing errors and improving overall production efficiency
  • Develop clear strategies to ensure new PAT tools meet GMP requirements from the outset, facilitating smoother adoption in commercial settings