Fierce Pharma Fierce Pharma

GxP AI - How Quality Systems Can Responsibly Control AI to Enhance Productivity and Streamline Operations

60 minutes

As AI capabilities push into GxP regulated business functions, how can Quality and IT teams partner to ensure they are properly controlled?  Join us as a panel of experts walks you through emerging practices for how Life Sciences companies can integrate AI-based solutions into GxP functions responsibly. 

Topics included:

  • GxP use cases where AI is emerging

  • Quality System practices for managing AI in GxP

  • The role of vendors, IT and Quality in controlling GxP AI

  • Investments needed to scale AI capabilities into future GxP use cases



Bryan Ennis

Bryan Ennis is the Founder of Sware, a validation solution provider dedicated to rescuing life sciences companies from the grip of validation debt; the unpaid cost of release, testing, GxP, and business requirements. Previously, he ran Global Regulated Systems at Genzyme before joining Veeva, where he was on the founding team of the widely used Veeva Vault platform. He spent nine years at Veeva running the R&D Customer Success department. He has worked with over 150 life sciences companies to develop validation and IT quality strategy.

Jamie Hijmans GtX

Jamie Hijimans

Dr. Jamie Hijmans, President of Global Exponential Technologies (GxT), combines scientific expertise with regulatory knowledge to develop innovative AI-powered solutions for medical and regulatory writing. With a background in research and regulatory affairs, Jamie drives toward automation-based efficiency in regulatory and GxP processes, improving quality and productivity.

Michelle Vuolo

Michelle Vuolo

Michelle Vuolo is currently the Head of Quality at Tulip Interfaces, Inc., a platform developer that allows manufacturers of many industries to build digital content to manage their operations. Before joining Tulip, Michelle spent over 24 years in the biopharmaceutical and medical devices industries in quality control laboratories, engineering technical support, quality assurance management, and computerized systems compliance. Michelle has a strong understanding of the needs of the life sciences industry and is motivated to evolve stagnant ways of meeting compliance requirements, especially as it relates to the 4.0 world.

Madhavi Ganesan

Madhavi Ganesan

Madhavi Ganesan has over 20 years of experience in Computer Systems Validation, QA IT, and Quality Systems within medical device, pharmaceutical, and the biologics industries. Madhavi has worked extensively with life sciences to transform their IT Quality Management Systems and SDLC governance models to comply with current regulations and standards.  Madhavi supports clients through their evolving regulatory climates and successfully defends their compliance status to various regulators and auditors.

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60 minutes