Current and Future Trends in Visual Inspection/Quality Assurance of Parenteral Drug Products LyoHUB Workshop

Current and Future Trends in Visual Inspection/Quality Assurance of Parenteral Drug Products LyoHUB Workshop

Agenda

7:30 AM -- Registration. Please arrive by 7:45 AM to clear security.

Morning session

8:00 AM -- Opening remarks/welcome

Sajal Patel, Senior Director, AstraZeneca

Alina Alexeenko, Director, LyoHUB, Reilly Professor of Aero & Astronautics and Chemical Engineering, Purdue University

Eric Munson, Scientific Director,  LyoHUB, Department Head, Industrial & Molecular Pharmaceutics, Purdue University

Sajal Patel, Senior Director, AstraZeneca

8:30 AM -- Current Trends in FDA Review for Freeze Dried Products

David Anderson, Supervisor, CDER, FDA\

Steve Rhieu, Supervisor, CDER, FDA

9:30 AM -- PDA Interest Group Discussions on Lyo Cake Appearance Defects

Rick Watson, Global Visual Inspection CoE Lead at Merck / PDA Visual Inspection IG Co-lead Merck

10:00 AM -- GROUP PHOTO

10:10 AM -- Break

10:30 AM -- NIST Reference Materials: Applications in the Biotechnology Innovation Ecosystem

John Marino, Director of Biotechnology Accelerator, Emerging Technologies Accelerator Program (ETAP), NIST

11:00 AM -- Instructional Training Defect Library Development

Christopher Barnes, Senior Advisor Global Visual Inspection Steward, Eli Lilly & Co

11:30 AM - Lunch and poster session

Afternoon session 

12:30 PM -- Advanced technologies in Automated Visual Inspection and Environmental Monitoring for Parenteral Drug Manufacturing (liquid and lyophilized formulations)

Multi-Modal Imaging and AI Framework for Advanced Visual Inspection of Parenterals

Alina Alexeenko, Director, LyoHUB, Reilly Professor of Aero & Astronautics and Chemical Engineering, Purdue University

Advanced technologies in Environmental Monitoring

Garth Simpson, Professor, Analytical Chemistry, Physical Chemistry Purdue University

1:15 PM -- Vendor Forum on Visual Inspection Technologies: Capabilities, Challenges, and the Path Forward

Barbara Casarin, Senior R&D Specialist, Stevanato

Louis Doneck, Sales Manager-Inspection, Körber

Ron Lawson, Director of Operations, Prime Results

James Mellman, Head of Business Development and Sales, N. America, WILCO

2:30 PM -- Break 

3:00 PM -- Lyophilized Drug Product Visual Appearance: Does Fogging Impact Container‑Closure Integrity?

Markela Murphy, Senior Scientist, AstraZeneca

3:30 PM -- PANEL: Responding to Challenges and Advanced Emerging Technology Programs – Barriers/Challenges

Moderators:

Alina Alexeenko, Director, LyoHUB, Reilly Professor of Aero & Astronautics and Chemical Engineering, Purdue University

Maxwell Korang-Yeboah, Senior Pharmaceutical Scientist, CDER, FDA

Panelists:

David Anderson, Supervisor, CDER, FDA

Leiyun Boone, Lead Biologist, CDER, FDA

Jeff Najarian, Associate Director of Vaccine Manufacturing Engineering at Merck & Co., Inc.,

Sajal Patel, Senior Director, AstraZeneca

4:30 PM -- Closing remarks

Alina Alexeenko, Director, LyoHUB, Reilly Professor of Aero & Astronautics and Chemical Engineering, Purdue University

Eric Munson, Scientific Director,  LyoHUB, Department Head, Industrial & Molecular Pharmaceutics, Purdue University

4:45 PM - 6:00 PM -- Networking Reception and Poster Session
sponsored by The William D. and Sherry L. Young Institute for the Advanced Manufacturing of Pharmaceuticals