
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...
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The pharmaceutical industry is a fascinating and complex field. It takes countless of people to bring a product to the market. In the Qualitalks Podcast, I bring to you experts, leaders, and...

What does it take to keep pharma & biotech CDMOs inspection‑ready across global sites? Senior VP of Global Quality, Melanie Kearney, reveals...

Yan Kugel is joined by Elizabeth Hickman , the CEO at AustinPx . With over a decade of experience in the biotech and pharmaceutical sectors,...

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 sh...

In this episode, Yan Kugel is joined by Christy Mazzarisi , a distinguished leader in the pharmaceutical industry with extensive experience...

In this episode, Yan Kugel is joined by Simone Ammons , a dynamic engineer, technical writer, and entrepreneur who has navigated through div...

In this episode, Yan Kugel is joined by Ben Coverdale, PhD, a seasoned global account director at Patsnap with a strong background in the li...

Yan Kugel is joined by Pavan Pasupulati , the Vice President of Manufacturing Excellence at Caliber Technologies. Here, he shares valuable i...

Yan Kugel is joined by Vincent F. Cafiso , the Director of Quality and Regulatory Services at CREO Consultancy and a former FDA investigato...

In this episode, Yan Kugel is joined by Mohamed Amer, a seasoned executive with over 20 years of experience in strategic and commercial lead...

In this episode we are joined by Kelly Stanton , the Head of Quality Systems Improvement at Corden Pharma. Kelly discusses her transition ba...

Yan Kugel is joined by Nagesh Nama, CEO at xLM who brings a wealth of experience and expertise in incorporating AI into validated processes...

Yan Kugel is joined by Lesley Worthington, a communication and leadership coach for quality professionals. Together, they discussed the sig...

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...

In today's episode, our guest is Vivek Gera , the CEO of Leucine and a seasoned process engineer. Vivek has a wealth of experience leveragin...

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...

Yan Kugel is joined by Paul Sarrazin, an esteemed expert in good distribution practices (GDP) within the pharmaceutical sector. Here, he pr...

In this episode, we welcome Jennifer Chang , a QA Intelligence Specialist at Blue Mountain . Yan Kugel and Jennifer discuss the impact of di...

In this podcast episode, we had the pleasure of hosting Fabrizio Maniglio , an industry Business Development Director at Honeywell with a we...

In today's episode, we have a special guest, Harsh Thakkar, who has made a successful journey into consulting within the pharmaceutical indu...

Yan Kugel is joined by Amar Badwy, the CEO at Pharmaoffer , to discuss digitalization in the pharma industry and the trends in the API marke...

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...

In this podcast episode, Nathan Roman joins us to discuss the importance of temperature-controlled transport and the two types of storage so...

In the latest episode of Qualitalks, Yan Kugel and Nathan Roman dive deep into the world of qualification protocols and share their insights...

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 most common concerns in GxP quality is maintaining the temperature of laboratory and manufacturing storage environments. Temperat...

Steve Galen has been involved in clinical trials for more than 27 years now, in various high-level positions. In this podcast episode, he wi...

In this podcast episode, our guest is Chris Maughan , a Sterilisation and Validation Consultant. Chris has spanned over 16 years with areas...

Excipients are an integral part of any pill, and they are becoming more complex with time. The complexity plays a significant role from the...

In this podcast episode, our guest is Troy Fugate , a pharma industry and GMP veteran with 30+ years of experience in the field. Now, he is...

In this podcast episode, our guest is Marc García Gómez , a pharmaceutical contamination control strategy consultant. He is also the author...

In this podcast, Yan Kugel and our guest Jerry Chapman talk about how the landscape has changed over the years in the Pharma industry and wh...

In this podcast, our guest is Jerry Chapman , a GMP expert with more than 40 years in the industry. Jerry and Yan talk about what has change...

In this podcast, Yan Kugel and our guest Megann Löffler talk about the new trends in the pharmaceutical industry, what you need to know abou...

In this podcast, Luis Charles Chavarría shares his invaluable insights from his 30-year career in the FDA. He explains how the FDA really op...

In this podcast, we have with us Yan Leyfman, MD. We will discuss and ask Dr. Leyfman about his views regarding how medicine and medical res...

In this podcast, we talk about CMOs and CDMOs, i.e., Contract Manufacturing Organizations. What they are, how they work, their past and expe...

In this podcast, Yan Kugel and our guest Rizgar Saltik talk about networking, branding, and marketing using LinkedIn, arguably the best onli...

In this podcast with Kurt In Albon , we will look at the concept of true leadership and its importance in the pharmaceutical industry. Kurt...

In this podcast, we have Philippe Tschopp from Glatt Pharmaceutical Services , a specialized CDMO. We will discuss with Philippe about CDMOs...

In this podcast, Yan Kugel and our guest, Àngels Llarch , talk about how pharma companies should host external audits. Àngels shares some re...

Christy Mazzarisi is the Global Lead of Quality at CGI, supporting clients with automation quality systems. In this episode, Christy talks t...

Yuval Shapiro is the founder of Quality with Value Ltd. A company that provides QA/RA for Medical Devices Services. Yuval is a Quality Assur...

Suzzane Studinger has been a GMP consultant for over 9 years now. In this podcast episode, she explains why she decided to leave her steady...

James Ainsworth is a software developer who started supporting businesses with ERP deployment and CSV about ten years ago. Besides the pharm...

"QA is a service provider and not a slave of the regulations." - Yaron Ziv Yaron is a pharmacist and the Head of QA at Chemipal, a medicinal...

In this podcast episode, Yan Kugel talked to Galit Lisaey about connecting the dots in data integrity. Galit Lisaey is a Data Integrity cons...

GMP training is mandatory, but nobody explains how to conduct it correctly, effectively, or measure results. Dominic Parry is the Director o...

Davidek Herron is the Head of Global Digital Platforms & Operations at Teva Pharmaceuticals . His mission in Teva is to leverage digital tec...

In this podcast episode, Vlatko Kantardjioski gives an amazing overview of equipment qualification in the pharmaceutical industry. Vlatko is...

Do you know what cloud computing is and how to validate it for pharma use? You will know by the end of this episode. More and more software...