Validating AI for Visual Inspections Webinar – May 2025
May 27 @ 10:00 am - 11:00 am CDT
Validating AI for Visual Inspections Webinar
Artificial Intelligence is everywhere. In January 2025 the FDA released – Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry and Other Interested Parties. PBL and ProPharma unlock the mysteries of how AI works in visual inspection and provides insights into how to utilize A.I. technology to inspect and release GxP products in a compliant way.
In this is free 1-hour webinar, you will learn:
- The current regulatory thinking on the use of A.I.
- What is an image and the image evaluation process
- What is a contaminant
- Challenges and solutions to visual inspection
You will discover the methodology for utilizing A.I. and how it can be validated for processing. This webinar also provides you with a visual representation of how A.I. utilizes images to assess the pass / fail standards and how those standards are maintained for simple products such as clear liquids and more complex applications like blood and plasma products.
Validating AI for Visual Webinar Topics
- How Artificial Intelligence (A.I.) is utilized to detect foreign materials
- Why AI is critical to assure safe drug supply
- How AI for Visual Inspection is implemented on IV bags and non-standard products
- How Visual Inspection with AI is validated per regulatory requirements
- Modifications required for AI to analyze difficult products including blood
- Considerations to resolve challenges of AI for blood, cell and gene therapies
Instructors
Robert Beall
Vice President ProPharma Cell and Gene Therapy Center of Excellence
Robert W. Beall – Vice President, ProPharma Group has 35+ years of industry experience. Robert has supported the development and commercialization of multiple cell therapy products and processes including decentralization of CD19+ CAR T therapies, development of hospital cellular therapy labs, including expansion of the NIH Center for Cellular Engineering, as well as the expansion of the first commercialized CAR-T therapy process capabilities. Other Cell therapy programs included remediation support for cellular and media manufacturing programs, and guidance for multiple CAR-T manufacturing automation advancements. Robert supported the COVID-19 response by establishing global safety systems for three major vaccines. He has led hundreds of international product transfers utilizing both internal transfers and CMO’s at multiple top 10 Pharmaceutical companies. He is a graduate of the Rochester Institute of Technology (RIT) with a BS in Engineering and has completed advanced degree studies as well as completing his PMP certification. He is an international speaker and author.
Filippo Begarani
Research and Innovation Manager
Filippo Begarani is Head of Innovation at PBL SRL, overseeing new technology development. He serves on the Supervisory Board of Italy’s National Research Centre for Gene Therapy and RNA-based Drugs. Previously CEO of Omnidermal Biomedics, he led AI-based medical device development for skin ulcer monitoring. He holds a PhD in Molecular Biophysics from Scuola Normale Superiore, Italy, and an MSc in Electronic Engineering with a focus on nanotechnology from leading European universities.
Cost: Free
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