Conference Day Two
8.15 am Check in Morning Coffee & Light Breakfast
8:55 am Chair’s Opening Remarks
Navigating Regulatory & Compliance Challenges in PAT Implementation
- Nidhi Kotecha Program Director, Gates Biomanufacturing Facility
Synopsis
- Establish secure, reliable data practices that comply with regulatory standards for trustworthy, auditable records in PAT
- Develop robust data handling for machine learning inputs, ensuring quality and accuracy to support real-time decision-making
- Employ advanced PAT tools for compliance monitoring and error reduction, ensuring adherence to GMP standards for smoother commercial adoption
Advancing Production and Quality Control through PAT Innovation and Strategic Partnerships
9:30 am Optimizing Aseptic Production Efficiency via PAT-Driven Process Validations
- Andreas Kunov-Kruse PAT Specialist, Novo Nordisk
Synopsis
- Explaining PAT as a cornerstone in future Process Validations and a key enabler for OPV/CPV increasing
- Reducing Validation Time to Increase Throughput in Aseptic Production and serve more patients
- A new multimodal spectroscopy approach enables more accurate PAT-based process models
10:00 am Streamlining QC Testing to Enhance Production Speed & Quality
- Manoharan Ramasamy Director, Merck
Synopsis
- Implementing PAT to perform QC tests more quickly and efficiently, cutting down the overall production lead time
- Incorporating QC tests into the production line using PAT for immediate results, enhancing process streamlining and reducing bottlenecks
- Utilizing PAT to handle various QC tests, including impurity limits and container integrity, ensuring comprehensive quality checks
10.30 am Morning Break & Networking
11:30 am Strengthening Vendor Partnerships to Optimize PAT Solutions for Improved Production Efficiency and Quality
Synopsis
- Building robust relationships with vendors to ensure seamless integration of advanced PAT tools, enhancing overall production efficiency and quality
- Collaborating with technology providers to develop customized PAT solutions that meet specific manufacturing needs, driving innovation and process improvements
- Facilitating continuous communication and feedback with vendors, ensuring timely updates and advancements in PAT technologies, maximizing their impact on production processes
Enhancing Process Understanding & Control through Specialized Chemometrics Techniques & Quality Optimization
12:15 pm Enhancing Industrial Process Monitoring Through Multivariate Statistical Techniques
- Samira Beyramysoltan Senior Scientist, GlaxoSmithKline
Synopsis
- Exploring multivariate statistical methods and their applications in process monitoring
- Identifying the main challenges including model development, limited batch data, and model maintenance
- Implementing strategies for overcoming these challenges, such as using simulated batches and adaptive modeling
12.45 pm Lunch & Networking
1:45 pm Unlocking Process Insights With PAT & Advanced Chemometrics
- David Zamora Global Statistics and PAT Lead, Novartis
Synopsis
- Utilizing advanced PAT techniques to gain a comprehensive understanding of complex process interactions and variables
- Leveraging chemometric models to support data-driven decision-making, improving process reliability and product quality
- Applying mechanistic modeling to pinpoint critical process drivers, enabling targeted process improvements and optimizations
2:15 pm Roundtable Discussion: Enhancing Quality Control Through Compliance-Driven PAT Integration
Synopsis
- Exploring the distinctions between online and offline QC testing within PAT systems
- Discovering strategies for ensuring compliance while maintaining flexibility in QC processes
- Examining key regulatory guidelines and frameworks governing PAT integration in QC environments
- Addressing common challenges and pitfalls in achieving regulatory compliance during PAT implementation
- Examining the importance of data integrity in PAT systems and impact on QC
Implementation Driving PAT Success: Enhancing Organizational Efficiency, Financial Performance and Talent Development
3:00 pm Optimizing Organizational Structures for Enhanced PAT Integration and Efficiency
- Emmanuel Appiah-Amponsah Director, Data Rich Measurements - Analytical Enabling Capabilities, Merck
Synopsis
- Integrating PAT teams within process development or analytical teams ensures effective usage, enhancing process understanding, control strategies and release testing
- Facilitating collaboration between development and manufacturing teams prevents delays and promotes seamless PAT integration into commercial manufacturing
- Aligning organizational structures to support analytical validation of RTRT improves accuracy and compliance in real-time data assessment