Pre-Conference Workshop Day - Tuesday September 9, 2025
8:00 am Check In, Coffee & Light Breakfast
9:00 am - 12:00 pm Workshop A
PAT in Action: Navigating the Transition from Development to Drug & Biologic Manufacturing
This interactive session will explore the challenges in bringing PAT tools from the development to manufacturing space. Attendees will have the opportunity to create implementation plans and crowd-source solutions for scaling PAT technologies and models.
Key Topics Discussed:
- Understanding scaling challenges by exploring the differences in lab-scale
development versus full-scale manufacturing - Addressing integration issues by discussing how to achieve compatibility with
existing manufacturing processes, data management, and system integration - Interactive Exercise: In small groups, participants will develop an implementation
plan for transitioning a PAT tool (e.g., Raman, HPLC online, soft sensors, or other) from the development stage to the manufacturing environment.
Key Takeaways:
- Understanding of how to develop a strategic implementation roadmap for PAT tools
Workshop Leader
Claudia Corredor
Senior Principal Scientist
Bristol Myers Squibb
12:00 pm Lunch Break
1:00 - 4:00 pm Workshop B
Strategic Validation of PAT Tools to Meet FDA & ICH Guidelines & Achieving Regulatory Compliance for Drug & Biological Product Manufacturing
This workshop will provide practical guidance on the validation of PAT tools in compliance with industry regulations and ensure attendees understand the core principles of validating models.
- Key Topics Discussed:
The key recent regulations and guidelines that govern the use of PAT in manufacturing of drugs and biological products - Interactive Exercise: working in groups, attendees will create validation plans for a given PAT tool or model which will include identifying key process parameters,
developing an appropriate risk management plan, and outlining how to document compliance
Key Takeaways:
- Understanding model validation workflows
- Addressing challenges for validating models for real time release testing (RTRT)
Workshop Leader
Farshid Mohammadparast
Principal Investigator,
Process Analytical Technology & Chemometrics
US Pharmacopeia