Risk Revolution
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Podcast Overview
<div>Welcome to Risk Revolution! The goal of this series is to advance the maturity of risk management practices within the industry, by covering topics that challenge quality professionals to seek opportunities to improve and advance the ways in which they perceive and manage risk.<br> <br> The hosts for this series are Nuala Calnan, Valerie Mulholland, and Lori Richter.</div>
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Publishing Since
5/11/2022
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Recent Episodes
July 5, 2026
37: When Change Management Becomes the Risk
<div> <p>Change management is intended to reduce risk—but what happens when the process itself becomes the biggest obstacle to improvement?</p><p>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. </p><p>They cover:</p></div><ul> <li> Why overly complex change management systems often discourage meaningful improvement </li> <li> The hidden risks of aging facilities, obsolete equipment, and deferred capital investments </li> <li> Why rejected changes should be documented—not simply forgotten </li> <li> How hazard registers can become more effective than traditional risk registers </li> <li> The importance of Gemba walks in identifying risks that metrics and dashboards often miss </li> <li> How quality culture influences risk management, change management, and leadership decision-making </li> <li> Why senior leaders need greater visibility into their organization's most significant risks </li> <li> Practical ways to simplify risk management while improving product quality, compliance, and patient safety</li> </ul><div>Show Notes:<br>PIC/s Document <a href="https://picscheme.org/docview/4294">https://picscheme.org/docview/4294</a><br><a href="https://www.lachmanconsultants.com/2025/08/change-management-change-control-enabler-or-blocker-part-1-of-2/">Change Management/Change Control (Enabler or Blocker?) Part 1 of 2</a><br><a href="https://www.lachmanconsultants.com/2025/08/change-management-and-ich-q12-part-2-of-2/">Change Management and ICH Q12 - Part 2 of 2 - Lachman Consultants</a> </div>
May 29, 2026
36: Can Annex 1 Deliver Better Risk Management?
<div><p> 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. </p></div>
May 1, 2026
35: From Protocol to Performance: Applying QRM to Improve Clinical Trial Quality
<div> <p>What does good risk management actually look like in clinical trials—and why are so many organizations still getting it wrong?</p><p>In this episode of Risk Revolution, the team explores how the latest update to <strong>ICH E6(R3)</strong> is reshaping clinical trial design and execution, with a deeper focus on <strong>risk-based thinking, patient-centricity, and quality-by-design</strong>.</p><p>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.</p><p>They cover:</p></div><ul> <li> Why risk management in clinical trials is often <strong>performed, but not truly integrated</strong> </li> <li> The shift toward <strong>quality by design at the protocol level</strong> </li> <li> How sponsors and CROs misalign on <strong>risk ownership and priorities</strong> </li> <li> Why many risk assessments fail to focus on what actually matters: <strong>patient safety and meaningful data</strong> </li> <li> The role of <strong>ICH E6(R3)</strong> in driving a more structured, risk-based approach </li> <li> How <strong>patient experience and feasibility</strong> should shape trial design </li> <li> Why over-reliance on templates, tools, and “check-the-box” processes can dilute real risk thinking </li> <li> Practical ways to implement <strong>risk-based decision-making without adding complexity</strong> </li> </ul><div> <p>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.</p><p>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</p><p><a href="https://www.ema.europa.eu/en/ich-e8-general-considerations-clinical-studies-scientific-guideline">Link to ICH E8 R1</a><br><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e6r3-good-clinical-practice-gcp">Link to ICH E6R3</a> <br><a href="https://www.eventbrite.com/e/applied-quality-risk-management-practical-skills-workshop-registration-1987016805755">PDA Southeast Chapter QRM Practical Workshop Registration Link</a> </p></div>
35 total episodes available
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Frequently asked questions
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- What is Risk Revolution?
<div>Welcome to Risk Revolution! The goal of this series is to advance the maturity of risk management practices within the industry, by covering topics that challenge quality professionals to seek opportunities to improve and advance the ways in which they perceive and manage risk.<br> <br> The hosts for this series are Nuala Calnan, Valerie Mulholland, and Lori Richter.</div> - How often does this podcast release new episodes?
This podcast updates daily.
- Where can I listen to this podcast?
This podcast is available on 9 platforms including Apple Podcasts, Spotify, and more. You can also use the RSS feed directly.
- Does this podcast accept guests?
Yes, this podcast regularly features guests.
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