Pharma Conversations Podcast

Pharma Conversations Podcast

Conversations with Leaders Shaping Pharma’s Future

  1. 2 hr ago

    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.

  2. 16 Jul

    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.

  3. 30 Jun

    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.

  4. 16 Jun

    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.

  5. 4 Jun

    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.

  6. 19 May

    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.

  7. 5 May

    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.

  8. 21 Apr

    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.

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Conversations with Leaders Shaping Pharma’s Future

Information

  • Creator
    Pharma Conversations Podcast
  • Years Active
    2026
  • Episodes
    14
  • Rating
    Clean
  • Copyright
    © Pharma Conversations Podcast
  • Show Website
    Pharma Conversations Podcast