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,, Bigfinite

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, Toni has led software projects for international pharmaceutical companies, covering the entire production process and supply chain. Today, Toni 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. Toni 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

Jordi Guitart, Ph.D., VP of Artificial Intelligence, Bigfinite

Jordi is General Manager for Customer Success leading a multifunctional team of solution architects, support engineers, and data scientists.

Jordi holds a PhD in Telecommunications from Universitat Politècnica de Catalunya. He has held top management positions in consultancy and technology companies and his career experience spans more than 25 years in areas ranging from software development, process engineering, analytics, and AI. Jordi has been working in the pharma arena for the last 15 years.

Message Presenter
Crystal Black, Aizon

Crystal Black, VP of Marketing, Bigfinite

Crystal is the VP of Marketing for Bigfinite owning and directing the marketing strategy for Bigfinite’s award-winning AI-informed data analytics solutions for the life sciences industry.

Crystal has been driving global marketing programs in the high tech space for over 2 decades and supporting data and analytics in the pharma space for 4 years. She earned a B.A. and an M.A. from Virginia Polytechnic Institute and State University and is a talented nature photographer and Jeep enthusiast.

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.

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