On-Demand

Smart PAT - Enhanced Process Control for Real-Time Release Testing (RTRT)

Process Analytics
Time
50 minutes

Join our webinar on the biopharma shift to Real-Time Release Testing (RTRT) via PAT. Discover how in-situ sensors like Incyte Arc, GlucoSense, and CO2NTROL cut data gaps and contamination risks while ensuring 21 CFR Part 11 integrity and faster scale-up.

What you will learn:

  • The Paradigm Shift to RTRT: Understand the regulatory and economic drivers moving the industry from traditional "Quality by Inspection" (end-product testing) to "Real-Time Release Testing" (continuous process assurance).
  • Defining the PAT Framework: Gain clarity on the relationship between CPPs (Critical Process Parameters), CQAs (Critical Quality Attributes), and KPIs (Key Performance Indicators) within a GMP-compliant framework.
  • Overcoming Analytical Bottlenecks: Identify common hurdles in off-line sampling—such as manual labor, 24-hour data gaps, and contamination risks—and how in-situ sensors like Incyte (VCD) and GlucoSense (Glucose) solve them.
  • Smart Sensor Intelligence: Explore the benefits of Arc Technology, including laboratory-based calibration, event-driven maintenance, and direct integration into PLC/SCADA architectures without external transmitters.
  • Digitalization & Data Integrity: Learn how to ensure CFR 21 Part 11 and Eudralex Annex 11 compliance through automated documentation, "Calibration Wizards," and secure data handling.
  • Accelerating Scale-Up: Discover how implementing Smart PAT in early Process Development (PD) creates a "Golden Batch" profile that streamlines tech transfer and reduces scale-up iterations.

Available Sessions:

Session 1: Tuesday, May 26th | 10:30 am CEST | 4:30 pm Standard China Time

Session 2: Thursday, May 28th | 11:30 am PST | 1:30 pm CST | 2:30 pm EST

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Speaker

  • Giovani Campolongo

    Giovanni Campolongo

    Senior Market Segment Manager Process Analytics, Hamilton

On-Demand webinar registration