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.
The hosts for this series are Nuala Calnan, Valerie Mulholland, and Lori Richter.
41: Beyond the Checkbox: Rethinking Employee Training Through Risk
What does it really mean for an employee to be qualified, and is completing training the same as demonstrating competence? In this episode of Risk Revolution, Lori Richter welcomes learning and development expert Nathan Profehl to explore how pharmaceutical and life sciences companies can use risk-based principles to build more effective employee qualification programs. They discuss why traditional “read and understand” training often falls short, how to distinguish procedural notifications from meaningful training, and why qualification should focus on demonstrating the knowledge and skills employees need to perform their jobs successfully.
Following the interview, Lori and co-host Val Mulholland examine the broader risks associated with onboarding, employee development, and knowledge retention. They discuss the importance of tailoring training to individual experience, involving frontline employees in designing qualification programs, and creating procedures that serve the people using them rather than simply satisfying auditors. The conversation also highlights how effective knowledge management, thoughtful hiring practices, and risk-based training can improve employee performance, strengthen quality systems, and protect organizations from losing critical institutional knowledge.
Show Notes
Additional resources discussed in this episode:
eBook: Biopharmaceutical Training — Designing Effective Adult-Learning–Based Programs
(https://www.bioprocessintl.com/careers-training/ebook-biopharmaceutical-training-designing-effective-adult-learning-based-programs)
Integrating Knowledge Management into QMS for Early Stage Companies: A Practical Approach for Improved Business Performance and Growth, Part 1
(https://www.bioprocessintl.com/regulatory-affairs/integrating-knowledge-management-into-qms-for-early-stage-companies-a-practical-approach-for-improved-business-performance-and-growth-part-1)
Integrating Knowledge Management into QMS for Early Stage Companies: A Practical Approach for Improved Business Performance and Growth, Part 2
(https://eu-assets.contentstack.com/v3/assets/blt0a48a1f3edca9eb0/blt45eef1ff6944f7bb/68238642334da080426daf64/23-5-Richter2.pdf)
1 Oct 2026
40: How do you validate AI? Is validate even the right word?
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/ (https://blog.phanero.ai/)
ICH Q9 (R1) Training Materials: https://www.ich.org/page/quality-guidelines (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 (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 (https://www.youtube.com/watch?v=93cx5r3ub5I&list=PLY5Gm6o-46FUtColQY_vz4O5NzmRGzlay&index=11)
30 Aug 2026
39: Beyond the Risk Assessment: Building a Stronger QRM Culture
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.
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