- PCAugust 13 · 28 min
Use Less, Make More: Sustainability and the Future of Pharma - Michael Kilkelly
Sustainability in pharma isn’t a side project anymore – it’s fast becoming core operational excellence. In this episode of Pharma Conversations, we sit down with Michael Kilkelly (IBEC) to explore how Irish pharma is leading on decarbonisation, the real challenges behind scope 1–3 emissions, and practical ways to embed sustainability from the boardroom to the cleanroom. A must-listen for anyone serious about turning ESG into measurable results. Contact us at: pharmaconversationspodcast@gmail.com This episode is sponsored by Kaye.
- PCJuly 30 · 34 min
Seeing What Matters: Modern Visual Inspection in Pharma - John Shabushnig
In this episode John Shabushnig, founder of Insight Pharma Consulting explains what visual inspection really means for injectable products, from manual methods to advanced automated systems. He tackles difficult-to-inspect products, visible particle risk, and common pitfalls in validating automation. John also shows how life-cycle thinking turns inspection data into real process and quality improvements. Contact us at: pharmaconversationspodcast@gmail.com This episode is sponsored by Kaye.
- PCJuly 16 · 52 min
Sterilisation of Indirect Product Contact Parts - Maria Ginnelly
In this episode of Pharma Conversations, Maria Ginnelly explains the impact of the EU GMP Annex 1 (section 5.5) on the sterilisation of indirect product-contact parts in sterile manufacturing. She explains why regulators now expect these parts to be treated as critical, why VHP alone is insufficient, and how legacy lines can use QRM, smoke studies, EM/PM, and enhanced gowning to build a defensible contamination control strategy. Maria also challenges equipment and wrapping vendors to rethink design for Grade A continuity, sharing practical, operator-focused ideas drawn from real-world experience. Contact us at: pharmaconversationspodcast@gmail.com This episode is sponsored by Orion GXP Consulting.
- PCJune 30 · 38 min
Launching Pharma in Europe - Charley Maxwell
In this episode, Charlie Maxwell of Orion GXP Consulting, breaks down what non‑EU pharma and biotech companies need to get right when launching in Europe, from choosing the right HQ location and operating model to deciding between building infrastructure and outsourcing to CDMOs, 3PLs and contract QPs. Charley explains why Europe is not one homogeneous market, how to avoid “tanking your pricing floor” through poor launch sequencing, and the crucial role of local quality, regulatory and distribution partners in making a European entry successful. Contact us at: pharmaconversationspodcast@gmail.com This episode is sponsored by Orion GXP Consulting.
- PCJune 16 · 52 min
AI in Pharma - Martin Lush
In this episode, Martin Lush of Martin Lush Consulting, breaks down how pharma organizations can safely and effectively adopt AI without sacrificing GMP, quality, or critical thinking. He explains the four types of AI mindsets in pharma, why “AI knows nothing,” and how overreliance and poor foundational knowledge create real risk. Martin also shares practical examples of prompt engineering, governance, and “expert-in-the-loop” approaches that turn AI from a hype-driven threat into a powerful accelerator for quality and productivity. Contact us at: pharmaconversationspodcast@gmail.com This episode is sponsored by Orion GXP Consulting.
- PCJune 4 · 46 min
Quality Culture - Craig Jacobs
In this episode Craig Jacobs, Quality Culture Momentum Specialist of Affirm8 Quality Consultancy, unpacks what “quality culture” truly means in life sciences organizations. He explains that real quality shows up when no one is watching on the night shift, in audits, and in everyday process execution. Craig introduces his “4 Ps” model as a way to both understand and measure quality culture over time. He also explores why the quality function often gets blamed when things go wrong, and how clearer accountability across the organization can transform both outcomes and mindset. Contact us at: pharmaconversationspodcast@gmail.com This episode is sponsored by STERIS.
- PCMay 19 · 46 min
Designing Tech Transfer for Reality - Joe Brady
In this episode, tech transfer expert and lecturer Joe Brady explains why most projects are “already late on day one” and unpacks the real causes of delay across the product lifecycle, from stability studies and PPQ batches to warehouses, materials, and analytical methods. He contrasts innovator to innovator with innovator to CMO transfers, shares hard‑won lessons on auditing, scaling legacy products, and soft‑skill pitfalls with CMOs, and explores how knowledge management, digitisation, and AI will reshape how pharma approaches tech transfer. Contact us at: pharmaconversationspodcast@gmail.com This episode is sponsored by STERIS.
- PCMay 5 · 45 min
Knowledge Management - Melanie Byrne Adams
In this episode of Pharma Conversations, we sit down with Melanie Adams, Associate Director, Knowledge Management at MSD, to unpack what knowledge management really is and how it can be embedded into everyday ways of working. Melanie shares practical strategies for capturing tacit knowledge (including the ROCK tool), accelerating speed to competency, and supporting regulatory readiness. Melanie also discusses the role of AI, digital tools, and communities of practice in breaking silos across global sites. Contact us at: pharmaconversationspodcast@gmail.com This episode is sponsored by STERIS.
- PCApril 21 · 48 min
Annex 1 in Practice: Contamination Control, Legacy Facilities & Global Lessons - Jim Polarine
In this episode, Jim Polarine from STERIS breaks down how Annex 1 is reshaping contamination control strategy world wide covering CCS design, risk‑based decision making, residue management, gowning, environmental monitoring, and material transfer pitfalls like cart wheels. He contrasts Europe and the US, explores the challenges of ageing facilities and new technologies. Contact us at: pharmaconversationspodcast@gmail.com This episode is sponsored by STERIS.
- PCApril 7 · 31 min
Disinfection Rotation - Laura Brennan
In this episode of Pharma Conversations, Laura Brennan Director of Technical Consulting at Ecolab breaks down the science and regulation behind disinfectant rotation in pharma cleanrooms, from the EU GMP Annex 1 and the FDA expectations to what actually works in practice. She shares new multi-site data on rotation strategies, how to use risk-based EM trends, when to escalate to VHP, and why hands-on training matters more than SOPs alone. Contact us at: pharmaconversationspodcast@gmail.com This episode is sponsored by Ecolab.
- PCMarch 24 · 25 min
Ireland’s Pharma Powerhouse: Investment, Innovation & Future Growth - Rory Mullen
In this episode, Rory Mullen, Head of Biopharma and Food at IDA Ireland, discusses how Ireland has evolved into a leading hub for pharmaceutical and biopharmaceutical manufacturing. He explores where the strongest growth is occurring from biologics and ADCs to GLP-1 weight-loss treatments and explains why global companies continue to invest in high-value operations in Ireland. He also highlights the role of AI, sustainability, and skilled talent in maintaining the country’s position at the forefront of the industry. Contact us at: pharmaconversationspodcast@gmail.com This episode is sponsored by Ecolab.
- PCMarch 10 · 45 min
Quality Risk Management - Kevin O'Donnell
In this episode of Pharma Conversations Podcast, Kevin O’Donnell (HPRA) explains how QRM needs to move beyond tick‑box exercises to become truly knowledge‑driven and evidence‑based. He walks through the main changes in ICH Q9(R1) and what regulators expect from companies in practice. We discuss culture, misuse of RPNs and the idea of a “living” QRM system under continuous improvement. Kevin also shares how these principles apply to emerging areas like ATMPs, digitalisation and AI. Contact us at: Pharmaconversationspodcast@gmail.com This episode is sponsored by Ecolab.
- PCS1 · E3February 24 · 29 min
Unannounced FDA Inspections - Patrick Nieuwenhuizen
In this episode of Pharma Conversations, we’re joined by Patrick Nieuwenhuizen, a global leader in pharmaceutical quality, compliance, and sterility assurance with more than 30 years of experience across sterile manufacturing, biologics, and advanced therapies. Together, we explore the realities of unannounced FDA inspections, the shift toward permanent inspection readiness, and the cultural, operational, and knowledge‑management foundations needed to withstand modern regulatory scrutiny. Contact us at: Pharmaconversationspodcast@gmail.com This episode is sponsored by Ecolab.
- PCFebruary 10 · 45 min
2026 Inspection Readiness and Lessons Learned - Kevin O'Donnell
In this episode of Pharma Conversations, we’re joined by Kevin O’Donnell, Market Compliance Manager and Senior GMP Inspector at the HPRA, to discuss what good inspection readiness looks like from a regulator’s perspective. Kevin shares common inspection gaps, how organisations can build continuous readiness, and insights on data integrity, people preparedness, and outsourced activities. He also reflects on his experience working in Japan, exploring its culture of quality and lessons for the Irish and European pharma industry. Contact us at: Pharmaconversationspodcast@gmail.com This episode is sponsored by Ecolab.
- PCS1 · E1January 26 · 29 min
Pharma’s Biggest Industry Trends and Challenges - Matt Moran
Matt Moran breaks down the challenges shaping the pharmaceutical industry from supply‑chain fragility and increasing regulatory complexity to the urgent need for sustainability and skilled talent. He highlights why the industry must modernise manufacturing, embrace digitalisation, and build greater resilience to stay competitive in a rapidly shifting global landscape. Matt is a prominent Irish biopharmaceutical industry expert, consultant, and former Director of BioPharmaChem Ireland (part of IBEC), where he spent three decades shaping Ireland's reputation as a global life sciences hub. He is currently an independent consultant, a board member of industry groups, and acts as a judge for industry awards. He is also Chair of the ARC Hub for Therapeutics Governance Committee. Contact us at: Pharmaconversationspodcast@gmail.com This episode is sponsored by Ecolab.