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

Change management is intended to reduce risk—but what happens when the process itself becomes the biggest obstacle to improvement?

In this episode of Risk Revolution, Nuala Calnan is joined by Paddy Costello, Senior Director at Lachman Consultant Services, to explore how overly complex change management systems, aging facilities, and ineffective risk oversight can quietly increase risk instead of controlling it. Drawing on experience as both a regulator and industry leader, Paddy shares practical insights into why organizations struggle to implement meaningful change, how leadership teams can better understand their most significant operational risks, and why risk management must move beyond documentation to support better decision-making.

They cover:

• Why overly complex change management systems often discourage meaningful improvement
• The hidden risks of aging facilities, obsolete equipment, and deferred capital investments
• Why rejected changes should be documented—not simply forgotten
• How hazard registers can become more effective than traditional risk registers
• The importance of Gemba walks in identifying risks that metrics and dashboards often miss
• How quality culture influences risk management, change management, and leadership decision-making
• Why senior leaders need greater visibility into their organization's most significant risks
• Practical ways to simplify risk management while improving product quality, compliance, and patient safety

More than a year after Annex 1 came into force, many organizations are still grappling with the challenge of turning contamination control strategies and risk assessments into meaningful operational practice. Recorded live at the ISPE Ireland Affiliate INSPIRE event in Cork, Nuala Calnan and Valerie Mulholland are joined by Richard Denk to discuss the current state of Annex 1 implementation, the gaps regulators continue to identify, and why the future lies in designing risks out rather than documenting them away. Along the way, they explore contamination control strategies, operator involvement in risk assessments, automation, robotics, and the evidence needed to demonstrate that risk controls are truly effective.

What does good risk management actually look like in clinical trials—and why are so many organizations still getting it wrong?

In this episode of Risk Revolution, the team explores how the latest update to ICH E6(R3) is reshaping clinical trial design and execution, with a deeper focus on risk-based thinking, patient-centricity, and quality-by-design.

Joined by clinical quality expert Joy Whitsett, the discussion moves beyond theory to examine how risk management is really being applied—and where gaps still exist.

They cover:

• Why risk management in clinical trials is often performed, but not truly integrated
• The shift toward quality by design at the protocol level
• How sponsors and CROs misalign on risk ownership and priorities
• Why many risk assessments fail to focus on what actually matters: patient safety and meaningful data
• The role of ICH E6(R3) in driving a more structured, risk-based approach
• How patient experience and feasibility should shape trial design
• Why over-reliance on templates, tools, and “check-the-box” processes can dilute real risk thinking
• Practical ways to implement risk-based decision-making without adding complexity

The key takeaway: effective risk management isn’t about doing more—it’s about focusing on what matters most, earlier in the process, and aligning teams around real-world outcomes.

For professionals working across clinical, quality, and regulatory functions, this episode offers a clear look at how risk thinking is evolving—and what it takes to apply it in practice

Link to ICH E8 R1
Link to ICH E6R3
PDA Southeast Chapter QRM Practical Workshop Registration Link

Is the new ICH Q9 training just more guidance—or a reset for how risk should be managed?

In this episode, we break down the latest training materials and what they signal for Quality Risk Management (QRM) in practice.

We cover:

• Why this release feels like a shift in expectations—not just an update
• The gap between risk tools and real decision-making
• Challenges applying dense guidance in real-world settings
• What organizations may need to rethink in existing QRM programs

If your team is focused on completing risk assessments rather than improving decisions, this episode will challenge your approach.