GCP Rewired - Nov 10 | 11-12:30 PM ET
Real AI Use Cases for GCP Inspection Readiness, Scaled for Any Organization
Real case studies in clinical quality are hard to find. Ones that are actually transferable to your organization are even harder.
Kevin Richards leads Clinical Quality at AstraZeneca, where his team has moved beyond AI pilots to operationalizing AI across clinical quality and inspection readiness. In this session, he opens the playbook: the types of AI his team is using, what problems they were built to solve, what they learned along the way, and what it would realistically take to apply the same thinking at your organization.
This program is for quality and clinical operations professionals who are past the “why AI” question and ready for the “how, exactly, and can we do it too” conversation.
Participants leave with
- A firsthand look at how AstraZeneca is operationalizing AI to strengthen GCP quality oversight and continuous inspection readiness.
- Three real-world AI use cases, including how they were developed, what worked, what didn't, and lessons learned.
- An understanding of where AI can deliver the greatest impact across GCP quality, from identifying emerging risks to enabling proactive oversight and strengthening inspection readiness.
- A practical approach to evaluating AI opportunities, including how to assess organizational readiness and align technology investments with quality priorities.
- Realistic next steps for your organization, including what to prioritize, what to defer, and how to make progress with the resources you have.
Session Topics
THE FRAMEWORK THAT MAKES AI WORK IN A GxP ENVIRONMENT
Why AI in Quality Stalls, and What Helps Move It into Practice
INSIDE THE USE CASES: WHAT AZ ACTUALLY BUILT
- #1 Automated Signal Detection from Structured Data
- #2 Proactive Inspection Readiness at Scale
- #3 See Quality Issues as a System, Not a Stack of Ticket
HOW TO APPLY THIS AT YOUR ORGANIZATION
From AstraZeneca's Scale to Yours - What's Transferable and in What Order
Expertise
Kevin Richards
Kevin Richards is Head of Clinical Quality at AstraZeneca, where he leads a team of 30 professionals responsible for quality oversight across a global clinical development portfolio. He has led the design and implementation of a digital quality operating model that connects quality signals to accountable workflows, automates manual burden at scale, and makes inspection readiness a continuous, evidence-based capability rather than a pre-inspection activity. He brings an analytics background and outside-industry perspective that shapes how he approaches problems the industry has long accepted as unsolvable.
Kristen Hunter
Kristen Hunter is the Founder of KH Conferences & Consulting, bringing more than 25 years of experience designing and producing educational conferences for clinical research professionals. A Certified Event Designer, she combines deep industry knowledge, strategic content development, and an extensive professional network to create experiences that connect experts with the audiences who need to hear from them. Throughout her career, she has built and led successful conference portfolios, earning a reputation for bringing complex industry challenges into focus through candid conversations, practical insights, and meaningful audience engagement.