The Qualitalks Podcast

By Qualistery

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 new... more

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FAQs about The Qualitalks Podcast:

How many episodes does The Qualitalks Podcast have?

The podcast currently has 78 episodes available.

The Qualitalks Podcast episodes:

April 29, 2026 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.
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Visit www.qualistery.com for live free webinars for GxP professionals, to stay on top of the latest industry trends.

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56min
November 26, 2024 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.
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34min
September 03, 2024 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.
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44min
August 27, 2024 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.
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52min
August 21, 2024 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.

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47min
August 13, 2024 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.

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40min
August 06, 2024 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.
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40min
July 31, 2024 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.
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58min
July 23, 2024 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.
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53min
July 16, 2024 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 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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54min

FAQs about The Qualitalks Podcast:

How many episodes does The Qualitalks Podcast have?

The podcast currently has 78 episodes available.