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Wednesday, June 19 • 8:00am - 9:00am
#312: Revolutionizing Regulatory CMC and Advanced Manufacturing with the Power of AI: Unleashing Innovation and Efficiency

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-633-L04-P; CME 1.00; RN 1.00

This forum session will explore the transformative potential of Artificial Intelligence (AI) in biotech RA CMC and advanced manufacturing. Discover how AI can optimize processes, improve efficiency, and ensure compliance of your data.

Learning Objectives

Define key concepts and principles of artificial intelligence (AI) in the context of biotech industry, regulatory CMC and advanced manufacturing; Identify the potential applications and benefits of AI including how it can automate deviation and change control processes or support strategic decision-making; Discuss the benefits, challenges and cons of AI i.e. data integrity and security.

Chair

Grzegorz (Greg) Podrygajlo, PhD

Speaker

Application of AI Tools to Support the Decision Process in Regulatory CMC
Grzegorz (Greg) Podrygajlo, PhD

Use of AI and ML in Pharmaceutical Manufacturing: Case Studies from the Shop Floor and Regulatory Landscape
Gert Thurau, DrSc, PhD

How to Use GenAI in a Smart Way for Now and for the Future
Hubert Niewiadomski, PhD


Speakers
avatar for Grzegorz (Greg) Podrygajlo

Grzegorz (Greg) Podrygajlo

GRA CMC Director, Head of Global Manufacturing Support, CSL Behring, Switzerland
Grzegorz (Greg) Podrygajlo, PhD is Head of Global Manufacturing Support, Global Regulatory Affairs CMC for Biologics at CSL Behring. He obtained Master in Medical Biotechnology and PhD in Neuroscience. Greg leads Global Regulatory Strategy for optimal Change Control Process and Life... Read More →
avatar for Hubert Niewiadomski

Hubert Niewiadomski

Chief Executive Officer, Cledar, United States
Hubert Niewiadomski is the CEO of Cledar, a Machine Learning and Artificial Intelligence Development company partnering with private and public sectors. Hubert has been the key contributor to more than 100 publications and has been working on neural networks for more than 20 years... Read More →
avatar for Gert Thurau

Gert Thurau

Head of Manufacturing Technology Innovation in CMC Regulatory Policy, F. Hoffmann-La Roche Ltd, Switzerland
Dr. Gert Thurau leads Manufacturing Technology and Innovation Advocacy at Hoffmann-La Roche, Basel, Switzerland. He advocates for advanced technology adoption in GMP manufacturing, including continuous processing, process models, robotics, advanced analytical technology, but also... Read More →

Wednesday June 19, 2024 8:00am - 9:00am PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  10: RegCMC-Product Quality, Forum