The Qualitalks Podcast

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  Reducing Risk and Costs: Continuous Water Quality Monitoring in Pharmaceutical Production 31.08.2026 33min

  In this episode, Yan Kugel and Konrad Sägesser discuss the latest trends and practical solutions in pharmaceutical water quality monitoring. Learn how continuous analytics, compliance, sustainability, and AI are reshaping water management in pharma manufacturing.Konrad is a Key Account Manager at Swan Analytical Instruments. He is a subject matter expert and co-author of the A3P Guidelines, alongside industry experts from Sanofi, BWT, and Veolia.
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  Overcoming Tech Transfer Bottlenecks: From Paper Trails to Standardized Digital Hubs [Nikki Bishop] 25.06.2026 51min

  Can a single click replace years of tech transfer paperwork? Nikki Bishop, VP of Marketing & Experience at Emerson , reveals how AI‑driven digitization could slash delays for pharma, biotech, med‑tech, and other regulated manufacturers.-------------------------Episode Sponsor: Emerson is a global leader in automation technology and industrial software, providing innovative solutions that help life sciences manufacturers optimize operations, enhance efficiency, and ensure regulatory compliance. With a focus on digital transformation, Emerson enables smarter, data-driven decision-making to drive productivity, quality, and sustainable growth in highly regulated industries.-------------------------Want to stay current with the latest GxP trends? Join our free, enlightening certification webinars at ⁠www.qualistery.com⁠.-------------------------For guest or sponsorship inquiries, contact us at [email protected]
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  Transforming Pharmaceutical Development with Active Packaging [Badre Hammond] 04.06.2026 44min

  Can custom active‑packaging technology add three years to a drug’s shelf life?Badre E. Hammond, Global VP of Aptar Active Material Science, reveals how early‑stage material science can slash development time, meet FDA/EMA requirements, and neutralize nitrosamine risks for pharma, biotech, and med‑tech leaders.Episode sponsor: Aptar Active Material Science is a premier active material science solutions expert that transforms ideas into market opportunities, accelerates and de-risks the product development process.-------------------------Want to stay current with the latest GxP trends? Join our free, enlightening certification webinars at www.qualistery.com.
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  How Process Analytical Technology Moves Quality into Real Time - Stanislav Kasakov 13.05.2026 57min

  Process Analytical Technology (PAT) has evolved from a niche troubleshooting tool into a strategic necessity—but most companies still implement it too late.  Dr. Stanislav Kazakov from Thermo Fisher Scientific reveals why starting PAT early can mean the difference between scaling success and costly manufacturing failures.Discover how real-time process insights, AI-driven chemometrics, and strategic implementation are reshaping quality control from lab to commercial scale across pharma and biotech.----------------------This episode is supported by Thermo Fisher Scientific. partners across the drug lifecycle to accelerate discovery, scale manufacturing, and ensure compliant release. Our analytical and process technologies support pharmaceutical and biotech teams from research and formulation through commercial manufacturing and quality control. With integrated instrumentation, workflow solutions, and expert service, we help protect yield, ensure data integrity, and deliver therapies to patients with confidence.----------------------Visit ⁠www.qualistery.com⁠ for live free webinars for GxP professionals, to stay on top of the latest industry trends.
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  Driving Global Quality in Viral Vector Manufacturing with Melanie Kearney 29.04.2026 55min

  What does it take to keep pharma & biotech CDMOs inspection‑ready across global sites? Senior VP of Global Quality, Melanie Kearney, reveals how she transforms quality culture, bridges R&D and manufacturing, and turns audits into a competitive advantage.The episode is supported by OXB. OXB is a quality and innovation-led viral vector CDMO, supporting its clients in delivering their life-changing therapies to patients around the world.--------------------------------------------Visit www.qualistery.com for live free webinars for GxP professionals, to stay on top of the latest industry trends.
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  Agility in Pharma: Transforming Challenges into Opportunities [Elizabeth Hickman] 26.11.2024 33min

  Yan Kugel is joined by Elizabeth Hickman, the CEO at AustinPx. With over a decade of experience in the biotech and pharmaceutical sectors, Elizabeth shares her insights on drug development, innovative manufacturing solutions, and the pressing need for sustainability in pharma.
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  Risks and Rewards in GMP Process Automation [Will Moss] #77 03.09.2024 43min

  In this episode, Yan Kugel is joined by Will Moss founder and CEO of Seal, about the critical need for automation in GXP processes. Will shares his expertise on balancing automation with human oversight, addressing data privacy concerns, and the future of quality management in the pharmaceutical sector.
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  Navigating Workplace Dynamics as a Woman in Leadership- Christy Mazzarisi #76 27.08.2024 51min

  In this episode, Yan Kugel is joined by Christy Mazzarisi, a distinguished leader in the pharmaceutical industry with extensive experience in quality systems and leadership roles. In this episode, we explore Christy's journey in pharma, her works, her impact on advocacy and leadership, and her vision for empowering women in the pharmaceutical industry.
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  Pharma Trends: The Return of the FDA Warning Letters - Simone Ammons - #75 21.08.2024 46min

  In this episode, Yan Kugel is joined by Simone Ammons, a dynamic engineer, technical writer, and entrepreneur who has navigated through diverse industries with finesse. She's the founder of the QneUp, a data-driven software tool that reduces equipment downtime and boosts productivity in the pharmaceutical industry. In this episode, we will be discussing data and FDA warning letters trends across the years with Simone.
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  The Impact of AI on Patent Research and Analysis in the Pharma [Ben Coverdale] #74 13.08.2024 39min

  In this episode, Yan Kugel is joined by Ben Coverdale, PhD, a seasoned global account director at Patsnap with a strong background in the life sciences and innovation and intelligence sectors. Ben brings a wealth of experience and insights into how AI and LLMs (Large Language Models) are transforming patent research and analysis in the pharmaceutical industry.
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  Navigating Complexity: Challenges and Solutions in Pharma 4.0 [Pavan Pasupulati] #73 06.08.2024 39min

  Yan Kugel is joined by Pavan Pasupulati, the Vice President of Manufacturing Excellence at Caliber Technologies. Here, he shares valuable insights into the future of pharmaceutical manufacturing. With over 25 years of experience in both the process and IT industries, Pavan has become a key figure in driving digital transformation within pharmaceutical manufacturing.
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  Navigating FDA Inspections: Things You Should Never Say! [Vincent F. Cafiso] #72 31.07.2024 57min

  Yan Kugel is joined by Vincent F. Cafiso⁠, the Director of Quality and Regulatory Services at CREO Consultancy and a former FDA investigator. Vincent shares invaluable advice on things never to say to an FDA investigator based on his extensive experience and expertise in the field. Join us as we uncover essential strategies and best practices to navigate FDA inspections with professionalism, compliance, and a proactive mindset.
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  The Strategic Journey of Pharmaceutical Commercialization [Mohamed Amer] - #71 23.07.2024 52min

  In this episode, Yan Kugel is joined by Mohamed Amer, a seasoned executive with over 20 years of experience in strategic and commercial leadership in the healthcare industry. Mohamed emphasizes the significance of CME (Continuing Medical Education) accreditation when promoting pharmaceutical products. He further discusses the challenges companies face in different countries regarding ethical standards and regulations when promoting pharmaceutical products.
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  Improving Processes: Insights and Transitions [Kelly Stanton]#70 16.07.2024 53min

  In this episode we are joined by Kelly Stanton, the Head of Quality Systems Improvement at Corden Pharma. Kelly discusses her transition back to the pharmaceutical industry after four years at Qualio, an eQMS provider. She also shares her improvement projects that make a real difference in her organization. Additionally, she shares insights on improving processes, the importance of regulatory compliance, and the impact of implementing changes within an organization. The conversation also delves into the benefits of using automated tools, making processes lean, and the significance of leveraging electronic tools to improve efficiency. Tune in to gain valuable insights into the pharmaceutical industry and the importance of continuous improvement in processes.
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  Revolutionizing Validation and Automation in Biotech [Nagesh Nama] - #69 09.07.2024 37min

  Yan Kugel⁠ is joined by Nagesh Nama, CEO at xLM who brings a wealth of experience and expertise in incorporating AI into validated processes within the pharmaceutical industry. Nagesh shares insights on the benefit challenges and best practices of using AI and machine learning technologies in pharmaceutical manufacturing quality. His insights shed light on the challenges and solutions in implementing AI in pharmaceutical manufacturing quality. The potential for AI to improve efficiency, reduce costs, and enhance regulatory compliance is evident, and the future of AI in pharma looks promising.
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  Navigating Communication Challenges in Quality-Driven Environments [Lesley Worthington] #68 02.07.2024 50min

  Yan Kugel⁠ is joined by Lesley Worthington, a communication and leadership coach for quality professionals. Together, they discussed the significance of interpersonal skills in the realm of quality assurance within the pharmaceutical industry. Lesley emphasizes that communication and interpersonal skills are often overlooked but are crucial for quality professionals. Technical knowledge is important, but it must be balanced with strong interpersonal skills to excel in the quality assurance field.
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  Experimenting with AI in Pharma: A Question of Time [Vasyl Chumachenko] 25.06.2024 47min

  In this episode, we will delve into the future of pharma and explore the intersection of AI, ML, and GMP compliance. Today, we are thrilled to have Vasyl Chumachenko, head of AI consulting at Data Science UA, join us as our esteemed guest. With a wealth of experience in integrating AI solutions into chemical and pharmaceuticals, Vasil brings a unique perspective on driving innovation and growth in the industry.
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  Enhancing Compliance and Efficiency in Pharma Manufacturing with AI [Vivek Gera] 18.06.2024 55min

  In today's episode, our guest is Vivek Gera, the CEO of Leucine and a seasoned process engineer. Vivek has a wealth of experience leveraging cutting-edge technologies to enhance compliance and operational efficiency within pharmaceutical manufacturing. Throughout this episode, we will delve into the transformative impact of AI on manufacturing, QA, and QC processes, shedding light on how these advancements are revolutionizing productivity and adherence to CGMP guidelines.
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  Revolutionizing Temperature Control in Pharma [Jakob Konradsen] 11.06.2024 53min

  Yan Kugel⁠ is joined by Jakob Konradsen, the Co-Founder & Head of Quality at Eupry and here he discusses the importance of moving away from paper or PDF calibration certificates and manual work in the GXP industry. They explore the idea of using machine learning algorithms for auditing and the need for a business continuity plan for temperature control. The speaker emphasizes the value of being prepared for potential issues and encourages professionals to focus on improving emergency response plans. The episode ends with a recommendation to connect with the speaker on LinkedIn for further discussions on temperature control.
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  How to Navigate GDP Compliance in Pharma [Paul Sarrazin] 04.06.2024 52min

  Yan Kugel⁠ is joined by Paul Sarrazin, an esteemed expert in good distribution practices (GDP) within the pharmaceutical sector. Here, he provides a glimpse into his journey from a permanent employee to a consultant specializing in GDP compliance. With a strong background in bioengineering and a rich portfolio of collaborations with industry giants like GSK, UCB, and Takeda, Paul's expertise in GDPs is rooted in his early consulting career and subsequent roles within pharmaceutical companies. Paul sheds light on the advantages of being a consultant in the pharmaceutical industry, emphasizing the autonomy and diversity of projects that come with the role.