Pre-Conference Workshops

December 5, 2023

Workshop A 10am-12.30pm

Enhancing Product Quality: Exploring QbD, Continuous Improvement, Real-Time Monitoring & PAT Integration in Manufacturing

Synopsis

Quality-by-Design (QbD) and continuous improvement practices play a vital role in enhancing product quality. By evaluating the effectiveness of QbD and continuous improvement this workshop will uncover strategies to achieve hgiher quality standards and optimize product performance.

Join this interactive workshop to:

  • Explore the benefits of leveraging real-time monitoring and control systems to detect the influence of Critical process Parameters (CPPs) on product quality
  • Evaluate how Quality-by-Design (QbD) and continuous improvement is used to enhance product quality to meet quality standards
  • Leverage real-time monitoring and control to detect how CPPs affect product quality, to reduce cycle times, improve resource utilization and cost savings
  • Exploring PAT’s role in the digital transformation of manufacturing
  • Optimizing a process map for successful deployment of PAT

12:30 pm Networking Lunch

Workshop B 1.30pm-4pm

Development Strategies & Machine Learning for Application in Cross-Manufacturing Environment

Synopsis

In this workshop, participants will gain valuable insights into the application of machine learning in a cross-manufacturing environment (Non GxP and GxP Environment). This knowledge will enable them to develop robust models, ensure compliance, and optimize manufacturing processes for enhanced product quality and operational efficiency. 

Throughout the discussion, essential topics will be covered; including the fundamentals of machine learning for bioprocessing in cross-manufacturing environments, effective strategies for data collection and preparation, model development techniques, data integrity and security considerations, root cause analysis, risk management, and validation and compliance requirements within GMP settings. 

This hands-on session will help you:

This hands-on session will help you:

  • Understand the fundamental concepts and principles of machine learning and its relevance for manufacturing intelligence in bioprocessing
  • Learn effective strategies for data collection, data interrogation, preprocessing, and data quality assurance to ensure reliable and accurate inputs for machine learning models
  • Explore various machine learning algorithms and techniques suitable for application in bioprocessing, including supervised, unsupervised, semi-supervised and reinforcement learning for tasks of classification, regression, and anomaly detection
  • Understand the regulatory requirements for model validation in cross-manufacturing environments, including validation protocols, performance metrics, and documentation
  • Uncover how to assess and mitigate risks associated with machine learning models in cross manufacturing processes including model accuracy, robustness, bias, and interpretability