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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.
Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/
Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/
Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions
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By Tyler MenichielloIn 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.
Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/
Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/
Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions