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          FDA/PQRI Workshop on the Regulatory Framework for the Utilization of Artificial Intelligence in Pharmaceutical Manufacturing - 09/26/2023Drugs Public
    Event Title
              FDA/PQRI Workshop on the Regulatory Framework for the Utilization of Artificial Intelligence in Pharmaceutical Manufacturing


                  September 26 - 27, 2023

  

    
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      Meeting InformationDate:
          
  


     
                                                       
       

September 26 - 27, 2023

 





About Workshop:

FDA and PQRI are excited to announce they will host an FDA/PQRI Workshop on the Regulatory Framework for the Utilization of Artificial Intelligence in Pharmaceutical Manufacturing on September 26 – 27, 2023, as a virtual event.

This FDA/PQRI Workshop will bring together leaders from regulatory agencies, industry, and academia to discuss critical topics related to the use of artificial intelligence (AI) in pharmaceutical manufacturing.

The National Academies of Sciences, Engineering, and Medicine (NASEM) noted that FDA is likely to see substantial innovations in pharmaceutical manufacturing which may impact process measurement, modeling, and control. AI technologies represent an area of rapid technology growth for designing, monitoring, and controlling manufacturing processes. Such AI technologies may challenge traditional approaches to regulating pharmaceutical manufacturing.

The FDA published a discussion paper on this topic in the Federal Register and has reopened it for public comment until November 27, 2023.

Workshop Objectives:

This workshop aims to facilitate interaction among AI stakeholders on critical areas for development, implementation, and regulatory consideration including uses in process development and control, operation of Pharmaceutical Quality Systems, lifecycle approaches, and Current Good Manufacturing Practice.

Meeting Information & Registration:

Workshop Dates: September 26 – 27, 2023

This virtual workshop is open to anyone interested in AI technologies in pharmaceutical manufacturing, specifically to learn from experts and contribute ideas. “Click here to register.”

Visit the Workshop website for more information.

For questions regarding this event contact the PQRI Secretariat at: PQRISecretariat@pqri.org. You can also visit the PQRI Website for updates.

                                                                                  Content current as of:
      09/27/2023
         
                   
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