Better Biopharma
“How can biopharma improve?” This question is the guiding ethos of the Better Biopharma podcast. Through conversations with experts across the biopharma landscape, host Tyler Menichiello explores the work being done to make better medicines and optimize manufacturing. Each episode is a dive into the guest's methods, their curiosity, and their determination. By shining a light on the visionaries pushing the industry forward, Better Biopharma aims to inform and inspire their peers to continue doing the same.
Better Biopharma
Data Governance And Regulations For AI Use In GMP With Peter Baker
In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Peter Baker, former FDA investigator and president of Live Oak Quality Assurance. They discuss Annex 22, the EMA’s GMP annex addressing the use of artificial intelligence (AI) in regulated manufacturing, including where it is sufficient and where it is lacking. Baker reflects on his time at the FDA and offers his own advice on AI and technology adoption and validation in GXP.
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