26/05/26

On Tuesday, May 26, join the webinar – provided by Hamilton – 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

door Idalia Dlugosz