Pre-Conference Focus Day

MARCH 23, 2021
10.00 - 17.00 EST I 7.00 - 14.00 PST

Implementing Continuous From Facility Design to Regulatory Filling

10:00 am Continuous Processing; A Process Architect’s View

  • Rob Bowen Director, Facilities Integration Ltd.

Synopsis

  • Risks, issues and Pharma4
  • Flows and impacts
  • Retrofit, stick and module
  • 20 years of studies, talk and now COVID-19. Are we there yet?

10:45 am Group Exercise: Facility Design for the Implementation of Continuous Processing

Synopsis

Discussion and troubleshooting:
• How to design a CM facility with a scale-out approach
• GMP cleaning considerations for continuous reactors to allow product changeover
• What questions should you be asking your architect?

11:15 am Capability Building for Continuous Manufacturing & Scale up

12:00 pm

Networking Refreshment Break

12:30 pm Modeling & Simulations for Continuous Manufacturing Applications

Synopsis

Modelling and Simulation technology holds great promise for reducing costs, improving quality, and shortening the time-to-market for process development and emerging therapeutics. However
these benefits are largely underutilized in industry to improve and advance continuous processes. This workshop will be led by Nima Yazdanpanah and help you reap the cost, quality and regulatory -related benefits to ensure a robust modelling and simulation strategy, tools, and applications.
In this 2 hour session we will explore:
• Modeling and simulation for CM process design, scaleup, integration, and technoeconomic analysis
• Modeling and simulation for CM process control, risk analysis, optimization, control strategy development
• Virtual twin for CM process evaluation, operator training, virtual doe, recipe and CPP optimization

2:30 pm IT Infrastructure Required to Support an Automated ‘Industry 4.0’ Facility

  • Navin Tiwari Head of Digital Shop Floor Automation, Sanofi

3:00 pm

Speed Networking

3:30 pm Group Discussion: Revolutionizing Your Regulatory Strategy

Synopsis

Tune your CMC regulatory strategy for Continuous. Through presentations, group discussions, gain insight on the following:
• Gaining regulatory Approval in CM
• Replacing “3 batch validation” in CM to ensure quality
• Defining Industry 4.0 data sets – how much data is required for continuous regulatory validation

5:00 pm

End of Preconference Focus Day