Why Biotech and Pharma Need GxP for their Digital Transformation Projects Now

Life Sciences, Pharmaceutical Regulation, Pharma Manufacturing & Supply Chain,
  • Monday, March 09, 2020 | 1pm EDT (10am PDT)
  • 60 min

Pharmaceutical manufacturers are under increasing pressure to fast-track technological innovation to improve their manufacturing operations in order to adapt to new approaches like ‘Industry 4.0’ and continuous manufacturing, combat the growing and intense competition and keep up with the increasing demand for personalized medicine and therapies. But with an industry with the world’s tightest regulations and complex value chains, what are the correct steps to reaching operational intelligence in a GxP compliant manner with end-to-end data integrity?

Attend this webinar to learn:

  • How Pharma 4.0 technologies like artificial intelligence (AI), machine learning (ML), Internet of Things (IoT), and data lakes used in conjunction can help you integrate and harmonize your data providing a holistic view of your operational environment
  • How to do compliant data acquisition and how safe it is to use AI/ML in a GxP environment and ensure data integrity, encryption, certification, and other key aspects of data management
  • Why you need GxP compliance IN your advanced analytics, data lakes, IoT, AI/ML
  • Why waiting for regulators to issue clearer guidance means you are already behind
  • How adopting these technologies result in huge benefits such as decreased downtime and increased productivity

How can you benefit?




Pep Gubau, CEO, Bigfinite

Pep Gubau is an entrepreneur and has been working in Information Technology (IT) for the last 25 years with companies pioneering Linux adoption in the 90s, cloud in the 2000s and big data and AI in the last decade. Although having an Economic Theory, Econometrics and Mathematics education, his early career was as a software developer in the chemical and pharma industry. He was later CTO & COO of a large IT consulting firm until 2003 when Pep founded his first IT company. Two more followed.

In 2013, Pep brought the inception of Bigfinite to his lifelong professional career partners, Pere and Toni, starting their current venture – the third iteration of their accumulated knowledge and expertise in the pharma industry, using the transforming new technologies now available.

Pep is an economist (University of Barcelona) with an engineering background and holds several international patents related to the encryption, transmission, storage and processing of large volumes of data for regulated environments in the cloud. Pep teaches IT topics regularly in several Masters programs in universities in Europe and the Americas and gives talks about the impact of big data, machine learning and advanced analytics. 

Born in Barcelona and raised in Italy (Ivrea, TO), Pep now lives in Tiburon, California, USA enjoying his five biggest passions: his wife and four children.

Message Presenter

Cristina Fernandez, Product Owner, Bigfinite

Cristina is a scientist with a passion for IT and new technologies. She has a bachelor’s degree in chemistry and holds a Ph.D. in science and technology applied to chemistry with special focus in data analysis (chemometrics).

She started her career in pharma in the UK working for AstraZeneca as a process analytical technology (PAT) specialist using spectroscopy to provide process optimization and understanding for pharmaceutical processes in both early and late stage projects enabling scale-up reducing risks.

She joined Bigfinite in early 2018 in quality assurance providing guidelines and training to developers about quality and compliance in pharmaceutical environments. Currently, she is the product owner and ensures the Pharma 4.0 technologies developed are ready to be used in GxP environments.

Outside work, what Cristina values the most is the time she spends with her family and friends. She lives in Reus, a small city near Barcelona close to the sea and the mountains where she can practice some of her favorite sports such as skiing and paddleboarding.

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

Attendees will learn about: 

  • Unknown future costs if your vendor doesn’t implement a GxP compliant integrated solution now
  • How the US Food and Drug Administration (FDA) is embracing new technologies and clearing the way for implementation… with caveats
  • The benefits of making the shift TODAY


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

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