Podcast · Tech & Science

The Qualitalks Podcast

by Qualistery · English · Tech & Science

A podcast about pharmaceutical manufacturing, quality, and GMP featuring the industry's top experts, leaders, and innovators. Listening to the podcast, you will learn about GMP best practices, the newest industry trends, innovative solutions, and career tips.

New episodes: Weekly
Typical length: 48 min
Latest: 12 Oct 2026
Language: English

Latest episode

12 Oct 2026 · 39 minNew

Preventing Alarm Fatigue in Life Science Facilities with EMS and Smart AI

Imagine missing a critical air‑handler failure because your BMS drowns you in 1,400 daily alarms—Stephen Tierney, President of Xiltrix, reveals how an independent EMS can turn blind spots into compliance‑savvy insights for pharma, biotech, and med‑tech. Yan Kugel then explores real‑world sensor placement, AI‑driven pattern detection, and the human‑in‑the‑loop strategy that lets quality leaders prevent costly downtime. ----------------------------------------------------------- This episode is supported by XiltriX . They provide 24/7 live agent monitoring for biotech and biopharma labs and…

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Earlier episodes 29 most recent

22 Sep 2026 · 40 min
Modernizing Pharmaceutical QC Laboratories From Locked Data to AI‑Powered Decisions [Jon Welsh]
Imagine unlocking 20 years of QC data to let AI forecast instrument downtime. John Welsh of Agilent reveals how the Allotrope simplified model and modern lab informatics turn compliance into a competitive edge. Discover why regulated pharma, biotech and med‑tech leaders can’t afford to ignore this shift. ------------------------- Episode Sponsor: Agilent is a global leader in life sciences, diagnostics and applied markets, recognized for uncompromising integrity in all we do. Our mission is to advance quality of life by focusing our expertise in six key markets: Food, Environmental and…
31 Aug 2026 · 33 min
Reducing Risk and Costs: Continuous Water Quality Monitoring in Pharmaceutical Production
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.
E81 · 25 Jun 2026 · 51 min
Overcoming Tech Transfer Bottlenecks: From Paper Trails to Standardized Digital Hubs [Nikki Bishop]
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…
E80 · 4 Jun 2026 · 44 min
Transforming Pharmaceutical Development with Active Packaging [Badre Hammond]
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?…
13 May 2026 · 57 min
How Process Analytical Technology Moves Quality into Real Time - Stanislav Kasakov
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…
E78 · 29 Apr 2026 · 56 min
Driving Global Quality in Viral Vector Manufacturing with Melanie Kearney
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…
26 Nov 2024 · 33 min
Agility in Pharma: Transforming Challenges into Opportunities [Elizabeth Hickman]
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.
3 Sep 2024 · 44 min
Risks and Rewards in GMP Process Automation [Will Moss] #77
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.
27 Aug 2024 · 51 min
Navigating Workplace Dynamics as a Woman in Leadership- Christy Mazzarisi #76
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.
21 Aug 2024 · 46 min
Pharma Trends: The Return of the FDA Warning Letters - Simone Ammons - #75
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.
13 Aug 2024 · 39 min
The Impact of AI on Patent Research and Analysis in the Pharma [Ben Coverdale] #74
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.
6 Aug 2024 · 40 min
Navigating Complexity: Challenges and Solutions in Pharma 4.0 [Pavan Pasupulati] #73
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.
31 Jul 2024 · 58 min
Navigating FDA Inspections: Things You Should Never Say! [Vincent F. Cafiso] #72
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.
23 Jul 2024 · 52 min
The Strategic Journey of Pharmaceutical Commercialization [Mohamed Amer] - #71
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.
E67 · 16 Jul 2024 · 54 min
Improving Processes: Insights and Transitions [Kelly Stanton]#70
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…
9 Jul 2024 · 37 min
Revolutionizing Validation and Automation in Biotech [Nagesh Nama] - #69
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.
2 Jul 2024 · 51 min
Navigating Communication Challenges in Quality-Driven Environments [Lesley Worthington] #68
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.
E66 · 25 Jun 2024 · 48 min
Experimenting with AI in Pharma: A Question of Time [Vasyl Chumachenko]
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.
E65 · 18 Jun 2024 · 56 min
Enhancing Compliance and Efficiency in Pharma Manufacturing with AI [Vivek Gera]
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.
E64 · 11 Jun 2024 · 53 min
Revolutionizing Temperature Control in Pharma [Jakob Konradsen]
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…
4 Jun 2024 · 53 min
How to Navigate GDP Compliance in Pharma [Paul Sarrazin]
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…
29 May 2024 · 50 min
Navigating the World of Asset Management and Quality Assurance [Jennifer Chang]
In this episode, we welcome Jennifer Chang , a QA Intelligence Specialist at Blue Mountain . Yan Kugel and Jennifer discuss the impact of digital transformation on manufacturing processes, the challenges and benefits of compliance in the pharmaceutical industry, and companies' struggles in keeping up with regulators and taking a risk-based approach. They also explore why companies switch to digitized solutions and the importance of continuous learning in the pharmaceutical industry.
22 May 2024 · 48 min
Unleashing the Power of AI in Pharma [Fabrizio Maniglio]
In this podcast episode, we had the pleasure of hosting Fabrizio Maniglio , an industry Business Development Director at Honeywell with a wealth of experience in Quality and Supply Chain Management within the life sciences sector. His insights into AI's transformative impact in the healthcare and pharmaceutical industries promise to make this conversation both enlightening and engaging. ------------------------------------------------------ The podcast is brought to you by ⁠Qualistery⁠ , a leading provider of webinars, training, and consulting for the pharma industry. For business inquiries,…
E60 · 15 May 2024 · 52 min
Breaking Barriers: How to Build a Successful Career in GMP Consulting [Harsh Thakkar]
In today's episode, we have a special guest, Harsh Thakkar, who has made a successful journey into consulting within the pharmaceutical industry. Harsh is a seasoned professional with extensive experience in advising on GXP practices and regulatory compliance. His career in consulting in the life science field is filled with insights, challenges, and triumphs that have shaped his career and made him a respected figure in the industry. The podcast is brought to you by ⁠Qualistery⁠ , a leading provider of webinars, training, and consulting for the pharma industry. For business inquiries, get…
E59 · 8 May 2024 · 55 min
Empowering Pharma Partnerships with Digitalization [Ammar Badwy]
Yan Kugel is joined by Amar Badwy, the CEO at Pharmaoffer , to discuss digitalization in the pharma industry and the trends in the API market. They talk about the changes and challenges in the industry, the importance of personal relationships in business, and the need for a more approachable and visible online presence for API manufacturers. They also discuss the impact of the pandemic on digitization and the evolution of Pharmaoffer as a marketplace for APIs and service providers in the pharmaceutical industry. The conversation provides valuable insights for API manufacturers and pharma…
S2 · E5 · 20 Jun 2023 · 39 min
Improving Manufacturing Efficiency and Compliance with Toon Lambrechts
In this episode of the Qualitalks Podcast, we are honoured to have Toon Lambrechts as our guest. Toon is a self-proclaimed biotech nerd with an impressive background in the field of advanced cell and gene therapies. In this episode, we’ll dive into Toon’s passion for democratizing access to these life-changing therapies and explore his work as a co-founder of MyCellHub , a SaaS solution for biomanufacturing. We’ll also discuss the current state of data management and documentation practices in GMP environments and the challenges they pose for the industry. Plus, we will explore how…
S2 · E4 · 29 Mar 2023 · 25 min
What Cold Chain Solutions Are There and How to Monitor Them [Nathan Roman]
In this podcast episode, Nathan Roman joins us to discuss the importance of temperature-controlled transport and the two types of storage solutions: active and passive. He explains that the cold chain includes all food, medicine, drug products, and vaccine-related equipment and procedures. Nathan mentions that understanding temperature-controlled options is essential to ensure the best-controlled system is chosen to protect temperature-sensitive pharmaceutical products. He also discusses the pros and cons of these cooling solutions and suggests that the decision on which solution is best for…
S2 · E3 · 22 Mar 2023 · 21 min
Temperature Mapping - All You need to Know About Good Qualification Protocols [Nathan Roman]
In the latest episode of Qualitalks, Yan Kugel and Nathan Roman dive deep into the world of qualification protocols and share their insights on writing effective ones. Nathan explains that a qualification protocol is a written plan describing the qualification process and how the qualification will be conducted. He emphasizes the importance of understanding the project and its requirements and suggests using templates or a basic protocol format to ensure consistency in documentation preparation. In addition, Nathan discusses the evolution of qualification protocols, including the…
S2 · E2 · 16 Mar 2023 · 17 min
Steps to Validating a Temperature Controlled Chamber [Nathan Roman]
Are you looking to learn more about how to validate a temperature-controlled chamber? Look no further! In this episode, we have Nathan Roman, one of the top experts in Temperature control mapping, to help us understand the different steps and regulations when validating a temperature-controlled chamber in the Health & Life Science industries. Nathan will share his knowledge on the need for temperature-controlled chambers, the various types of chambers, regulations, common mistakes to be avoided, and resources for keeping up with best practices Topics range from: What a temperature-controlled…

About The Qualitalks Podcast

The Qualitalks Podcast is a English tech & science podcast from Qualistery. Melo plays each episode straight from the publisher's own feed — no ads added, no account needed — and remembers where you stopped, in this browser only.

Publisher: Qualistery
Language: English
Category: Tech & Science
New episodes: Weekly
Typical length: 48 min
Latest episode: 12 Oct 2026
Feed: RSS — paste into any podcast app
Apple Podcasts: podcasts.apple.com/podcast/id1504428899
Rights: Qualistery

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