How Does AI Qualification Work?

Drug Discovery & Development, Life Sciences, Pharma Manufacturing & Supply Chain, Pharmaceutical Regulation,
  • Tuesday, May 05, 2020 | 10am EDT (NA) / 3pm BST (UK) / 4pm CEST (EU-Central)
  • 60 min

Quality is a big topic in pharma circles and can hinder progress towards the promises of digital transformation in manufacturing operations. This would solve many headaches from understanding your operational realities to quickly identifying the root causes for deviations and even the predictive capabilities of avoiding downtime. Artificial Intelligence (AI) promises deterministic predictions, recommendations, or classifications which has historically been done through mathematics and statistics, but can be done faster. This ultimately enables data scientists to focus on more pressing issues.

Questions regarding whether your organization can use AI algorithms will be answered, some include:

  • Will the US Food and Drug Administration (FDA) approve the use AI algorithms?
  • Does it follow regulatory guidelines, ALCOA principles, and Quality by Design (QbD) concepts?
  • How can I feel confident in the data and AI processes?

Join this webinar as Toni Manzano discusses why AI algorithms are not only a good idea, but even encouraged by regulating bodies.



Toni Manzano, PhD, Chief Science Officer, Bigfinite

Toni Manzano is a co-founder and CSO of Bigfinite, a SaaS company that is transforming manufacturing operations with the use of AI and industrial Internet of things (IIoT) technologies for pharmaceutical and biotech companies. For over two decades, Manzano has led software projects for international pharmaceutical companies, covering the entire production process and supply chain. Today,  Manzano  is part of the scientific committee with PDA Europe and with the AI Xavier Manufacturing team. He worked as a researcher at the University of Barcelona as a physicist and teaches big data and artificial intelligence in postgraduate courses at UAB. He is also a member of the Science Experts in the Spanish Parliament on big data and artificial intelligence. Manzano has written numerous articles and holds a dozen international patents related to the encryption, transmission, storage and processing of large volumes of data for regulated environments in the cloud. 

Message Presenter

Who Should Attend?

This webinar will be suitable for senior-level professionals working within:

  • Pharma Manufacturing
  • Manufacturing Operations
  • Quality
  • IT/OT
  • Innovation

What You Will Learn

Participants will gain insights into

  • The AI algorithms approved by the FDA
  • The way to follow regulatory guidelines, ALCOA principles and Quality by Design (QbD) concepts
  • Gaining confidence in the data and the AI processes

Xtalks Partner


Bigfinite is a solutions provider that transforms manufacturing operations with the use of advanced analytics, artificial intelligence, and pharma 4.0 technologies focused on optimizing pharmaceutical and biotech companies. The Bigfinite analytics platform seamlessly integrates unlimited sources of structured and unstructured data to deliver actionable insights across all manufacturing sites. Bigfinite offers an intuitive way to gain meaningful operational intelligence with data by enabling real-time visibility and predictive insights in a GxP compliant manner with end-to-end data integrity. Founded in 2014, the company is based in San Francisco, California and also has a European office in Barcelona, Spain.

Media Partner

The original site for employees in the pharma, medical, diagnostic and related industries. Our hand-curated daily news feed and active message forums will keep you informed.

You Must Login To Register for this Free Webinar

Already have an account? LOGIN HERE. If you don’t have an account you need to create a free account.

Create Account