Show Notes
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
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
More from Risk Revolution
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:
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:
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:
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:
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.