AI is already moving into GxP, sometimes through purpose-built AI applications and sometimes as new AI capabilities within software organizations already use. But how do we know when an AI application is trustworthy enough for a regulated use? And is traditional computer system validation even the right starting point?

Val talks with Andy O’Connor of Phanero about why “AI” is not one single technology and why the first question should perhaps not be “How do we validate it?” but “What are we asking it to do?”

SHOW NOTES:

• Phanero Blog: https://blog.phanero.ai/
• ICH Q9 (R1) Training Materials: https://www.ich.org/page/quality-guidelines
• EMA Annex 22 AI Expert Workshop June/July 2026: https://www.ema.europa.eu/en/events/good-manufacturing-practice-multistakeholder-workshop-expert-contributions-artificial-intelligence-guidance-development-annex-22?utm_source=chatgpt.com
• Risk Revolution Episode 28: Quality Theatre to Quality Science, Jeremiah Genest’s Playbook:https://www.youtube.com/watch?v=93cx5r3ub5I&list=PLY5Gm6o-46FUtColQY_vz4O5NzmRGzlay&index=11

Quality risk management should be more than a compliance exercise or another spreadsheet to complete. The real opportunity is to make it risk-based.

They cover:

• Why the industry is still struggling to fully embrace ICH Q9(R1)
• The shift from reactive risk assessments to proactive risk-based decision-making
• Why leadership, knowledge management, and organizational culture are critical to effective QRM
• How the new ISPE QRM Guide was designed as a practical handbook and toolkit for practitioners
• Why defining the right risk question should come before choosing a risk assessment tool
• How organizations can determine the appropriate level of formality for different risk scenarios
• The growing role of QRM in product availability and supply chain resilience
• Why practitioners should look beyond FMEA and consider different or combined risk tools
• How QRM can become an integrated part of strategic decision-making rather than simply a compliance requirement

The key takeaway: the future of QRM is not about doing more risk assessments. It is about creating a risk mindset where managing uncertainty becomes part of everyday decision-making across the organization. When risk management is integrated with knowledge, strategy, and business objectives, organizations can move from reacting to problems to identifying and addressing them before they happen.

thinking part of how organizations operate, make decisions, and protect patients.

In this episode of Risk Revolution, Nuala Calnan welcomes Dr. Alice Redmond, Chief Risk and Quality Officer at CAI and a longtime leader in the quality risk management community. They explore the current state of QRM across the life sciences industry, the persistent challenges following ICH Q9(R1), and the development of the new ISPE Quality Risk Management Guide.

Some of the most valuable lessons in risk management don't come from regulations or templates. They come from books that challenge how we think, make decisions, communicate, and lead.

In this special Book Club edition of Risk Revolution, hosts Nuala Calnan, Valerie Mulholland, and Lori Richter share the books that have most influenced their thinking about quality risk management, decision making, organizational culture, and leadership. They discuss practical lessons from Thinking, Fast and Slow, Upstream, Surrounded by Idiots, The Talent Code, and Deciding, while exploring how these ideas can improve risk assessments, strengthen decision making, and build more effective organizations. The episode also features Celeste Theberge of Takeda, who shares how her company's "Risky Reads" book club is helping develop quality risk management capability across the organization.

They cover:

• Why psychology and behavioral science matter in quality risk management
• The difference between reactive problem solving and preventing issues before they occur
• How cognitive bias and AI can influence decision-making
• Why communication styles can strengthen or weaken cross-functional teams
• Practical ways to build a stronger quality risk management culture through discussion and shared learning
• Lessons from Takeda's "Risky Reads" quality risk management book club
• Why assumptions should be challenged before important decisions are made
• The books every quality and risk professional should consider adding to their reading list