Artificial intelligence is no longer a future consideration for life sciences; it is actively reshaping how validation and quality teams work today. But adoption without governance is a liability. For organizations operating under GxP frameworks, the question is no longer whether to use AI, but how to implement it in a way that satisfies regulators, protects data integrity and delivers lasting operational value.
This webinar explores a practical five-pillar framework for AI governance in validation and explains how validation and quality teams can apply it to support the responsible adoption of AI.
Developed by digital validation experts, this framework gives validation and quality professionals a structured architecture for AI adoption, grounded in current regulatory expectations from the FDA, EMA and ISPE, and designed for the realities of modern GxP environments. Each pillar addresses a distinct dimension of governance, from risk classification and change control to auditability and human oversight, giving teams a clear foundation to build on rather than a checklist to react to.
Register for this webinar to learn how AI governance can help validation and quality teams implement AI responsibly in GxP environments.
Speakers
Amy Wilhite, Senior Solution Validation Engineer, Kneat
Amy is a highly experienced Validation Engineer with a demonstrated history of excellence in the biotechnology industry. She is an expert in laboratory operations, bioprocess manufacturing and equipment/facility/utility CQV/CSV.
Message Presenter
Gillian McMahon, Senior Product Owner, Kneat
Gillian is a Senior Product Owner at Kneat with seven years’ experience driving digital validation innovation. She currently leads initiatives focused on AI-enabled capabilities, enhancing compliance and efficiency within regulated environments.
Message Presenter
Ruairi McGarry, Senior Product Manager, Kneat
Ruairí McGarry is an experienced Engineer with over 10 years of experience in quality-regulated manufacturing. Prior to joining Kneat, Ruairí held various Project Engineering roles in the medical devices industry, working with Johnson & Johnson, Stryker and Depuy.
Message PresenterWho Should Attend?
This webinar is suited for validation and quality professionals considering using AI-supported software.
What You Will Learn
Attendees will gain insight into:
- The five pillars of effective AI governance
- Potential benefits of AI in validation and quality workflow
- How to mitigate risk with AI-enabled programs
Xtalks Partner
Kneat Solutions
Kneat Solutions is a leading validation software company at the forefront of digital transformation in highly regulated industries.
Its innovative software solution, Kneat Gx™, eliminates paper from all stages of the validation life cycle and integrates document management, process automation, and electronic signatures — enabling organizations to achieve and maintain regulatory compliance, improve operational efficiencies seamlessly, and simplify audits and inspections.
Trusted by eight of the world’s top 10 global life sciences companies, Kneat empowers businesses to navigate complex regulatory landscapes while reducing time-to-market, changeover, and cycle times, enhancing productivity by as much as 100%, and ensuring data integrity.
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