36: Can Annex 1 Deliver Better Risk Management?

36: Can Annex 1 Deliver Better Risk Management?

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.

35: From Protocol to Performance: Applying QRM to Improve Clinical Trial Quality

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 [https://www.ema.europa.eu/en/ich-e8-general-considerations-clinical-studies-scientific-guideline] Link to ICH E6R3 [https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e6r3-good-clinical-practice-gcp]  PDA Southeast Chapter QRM Practical Workshop Registration Link [https://www.eventbrite.com/e/applied-quality-risk-management-practical-skills-workshop-registration-1987016805755]

34: Is ICH Q9 Training a Reset for Risk Management?

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.

33: Beyond ‘Human Error’- Designing for Humans

In this episode of Risk Revolution, Val and Nuala are joined by Julie Avery and Dominic Furniss, both experts on Human Reliability, to tackle a stubborn challenge in pharmaceutical manufacturing quality: why we keep seeing repeat deviations, repeat CAPAs, and repeat “retraining’.    Julie and Dominic make a practical case for integrating Human Factors Engineering (HFE) into the PQS in a way that is not only cultural, but structured and auditable. Drawing lessons from other high-hazard industries (including COMAH), they outline what a pharma-focused human reliability guide could look like.   This conversation isn’t just theory. Julie and Dominic are actively building momentum, and they’re inviting quality leaders, practitioners, and learners to join a growing Community of Practice to share tools, case experiences, and practical ways to bring human reliability into real PQS work. If you’ve ever thought, ‘we keep fixing the symptom,’ this episode is for you.

32: Risk Thinking: From Tools to Judgement

In this episode, the hosts take a hard look at one of the most persistent challenges in modern quality risk management: why risk thinking feels natural in everyday life—but becomes so difficult at work. Moving beyond familiar tools like FMEA, heat maps, and scoring tables, the discussion explores what real risk thinking looks like in regulated environments—and why over-reliance on templates can sometimes suppress the very judgment and curiosity needed to manage risk effectively. Key topics include: * Why completing a risk tool doesn’t necessarily mean risk has been managed * The difference between risk analysis and risk-based decision-making * How compliance pressure, audit defensibility, and organizational culture shape behavior * What “good” risk-based decisions look like when information is incomplete * Practical ways teams can talk about risk without pulling up a template * The importance of humility, uncertainty, and learning from real-world outcomes The episode also connects today’s challenges to the evolution of ICH Q9 and the industry’s broader shift toward Quality Risk Management—asking whether the original intent has been lost along the way Show Notes: 1. Risk management basics: what exactly is it? [https://youtu.be/BLAEuVSAlVM?si=YiiztW4ZJbTgcnqY] David Hillson Risk Doctor  2. Lori's upcoming PDA West Coast Chapter Event [https://www.pda.org/global-event-calendar/event-detail/pda-west-coast-chapter-full-day-quality-conference#agenda]  3. Article: Steps Towards Demystifying Risk-Based Decision Making [https://www.pharmtech.com/view/steps-towards-demystifying-risk-based-decision-making] (Valerie Mulholland and Anne Greene  4. Valss Course on RBDM.... http://www.gmp.ie [http://www.gmp.ie/]   5. Val’s 8 steps to better Risk Thinking in RBDM [https://chatgpt.com/s/m_697a3dcef7608191879c368583a6bb18]