Annex 1 in Practice: Contamination Control, Legacy Facilities & Global Lessons - Jim Polarine

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.

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.

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.

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.

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.