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Overcoming Tech Transfer Bottlenecks: From Paper Trails to Standardized Digital Hubs [Nikki Bishop] Nikki Bishop
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Transforming Pharmaceutical Development with Active Packaging [Badre Hammond] Badre Hammond
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How Process Analytical Technology Moves Quality into Real Time Dr. Stanislav Kasakov
Digital records, AI support, shared industry standards, and stronger change management can help pharma teams move tech transfer faster, reduce manual work, and make handoffs between sites clearer and more […]
Dr. Stanislav Kasakov
Melanie Kearney draws on 30+ years across R&D, QC, radiopharma and viral vectors to show how cross-functional experience, visible leadership, and scalable QMS practices keep advanced therapies inspection-ready and patient-focused.
In this episode of The Qualitalks Podcast, Elizabeth Hickman discusses the dynamic landscape of the pharmaceutical industry. She shares insights on how companies are navigating challenges while turning them into […]
Yan Kugel is joined by Will Moss founder and CEO of Seal, to talk about the critical need for automation in GXP processes. Will shares his expertise on balancing automation […]
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 […]
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 QuneUp, a data-driven […]
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 […]
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 […]
Yan Kugel is joined by Vincent Cafiso, the Director of Quality and Regulatory Services at CREO Consultancy and a former FDA investigator. Vincent shares invaluable advice on things never to […]
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 […]
In this episode, Kelly discusses her experiences in the pharmaceutical industry and the challenges of implementing cloud-based software tools. She also shares insights on improving processes and the impact it […]
In this podcast episode, Nagesh Nama shares his expertise in incorporating AI into validated processes within the pharmaceutical industry. He discusses the benefits, challenges, and best practices of using AI […]
Yan Kugel is joined by Lesley Worthington, a communication and leadership coach for quality professionals, to discuss the importance of interpersonal skills in quality assurance within the pharmaceutical industry. Lesley […]
Vasyl shares his expertise in integrating AI solutions into the pharmaceutical industry and the practical implications of driving innovation and growth. The conversation delves into the use of AI and […]
Vivek shared his wealth of experience leveraging cutting-edge technologies to enhance compliance and operational efficiency within the pharmaceutical manufacturing industry. Throughout the episode, Vivek delved into the transformative impact of […]
Jakob Konradsen, the co-founder and head of quality at Eupry emphasized the importance of data integrity and advanced statistical analysis in the pharmaceutical industry. He discussed the challenges related to […]
Paul shares his wealth of experience and insights into innovative strategies and best practices for maintaining quality standards and regulatory compliance in the pharmaceutical supply chain. The discussion delves into […]
Join us for an insightful conversation with Jennifer, a quality assurance expert in the life sciences industry. Learn about the challenges and best practices in regulatory compliance and how continuous […]
abrizio Manilio discusses the role of digitalization and AI in the life sciences industry. He shares insights into the future of technology, the importance of understanding capabilities, and the potential […]
Our guest Harsh Thakkar shares valuable insights on building leverage, creating content, and the importance of online presence in the business world.
Explore digitalization in the pharma industry with Yan Kugel from Qualistery and Ammar Badwy from Pharmaoffer. Gain insights into trends in the API market, the impact of the pandemic, and […]
Join us as we dive into an insightful conversation with Toon Lambrechts, the Co-Founder of MyCellHub, in an exploration of advanced therapies and the democratization of access to life-changing treatments.
In this podcast episode, Yan Kugel interviews Nathan Roman about the importance of temperature control in the supply chain industry, specifically in the cold chain.
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.
In this episode, Nathan Roman shares his knowledge of the different steps and regulations when validating a temperature-controlled chamber.
In this podcast episode, Nathan Roman, one of the top experts in Temperature control mapping, speaks about thermal mapping and its importance for pharmaceutical compliance.
By listening to this episode of watching it, you will learn about: What Are Clinical Trials and How to Solve Its Biggest Challenges with Steve and Yan
In this podcast episode, our guest is Chris Maughan, a Sterilisation and Validation Consultant.
Excipients are an integral part of any pill, and they are becoming more complex with time. The complexity plays a significant role from the regulatory aspect and their role in […]
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 the Vice President at […]
In this podcast episode, our guest is Marc García Gómez, a pharmaceutical contamination control strategy consultant. He is also the author of various articles in Spanish pharmaceutical magazines about cleaning […]
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 what things have remained the […]
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 changed in pharma over […]
In this podcast, Yan Kugel and our guest Megann Löffler talk about the new trends in the pharmaceutical industry, what you need to know about the market and what the […]
In this podcast, Luis Charles Chavarría shares his invaluable insights from his 30-year career in the FDA. He explains how the FDA really operates, their main purpose during an audit, […]
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 research will look in the […]
In this podcast, Yan Kugel and our guest Rizgar Saltik talk about networking, branding, and marketing using LinkedIn, arguably the best online platform for professionals and business interactions. They also […]
In this podcast with Kurt In Albon, we will look at the concept of true leadership and its importance in the pharmaceutical industry. Kurt will tell us what essential qualities […]
In this podcast, we have Philippe Tschopp from Glatt Pharmaceutical Services, a specialized CDMO. We will discuss with Philippe about CDMOs, what they are, how they work, and what a […]
In this podcast, we talk about CMOs and CDMOs, i.e., Contract Manufacturing Organizations, what they are, how they work, their past and expected future, and everything you need to know […]
In this podcast episode, Christy Mazzarisi sheds light on artificial and automated intelligence in the Pharmaceutical GMP Industry.
Yuval Shapiro is a Quality expert and Six Sigma black belt. In this podcast episode he explains why quality is dying & how to save it.
Why would you leave a steady job to become a GMP consultant? Suzzane Studinger gives the answers in this Qualitalks Podcast episode.
In this podcast episode you will learn about crucial parts of CSV that nobody teaches you during official training.
In this podcast episode, Yan Kugel talked to Galit Lisaey about connecting the dots in data integrity.
Dominic Parry is the Director of Inspired Pharma and he explains how to perform effective GMP training and test effectiveness.
Borislav Milev is a CSV expert. In this podcast episode, he explains what cloud computing is and how to validate it in a GMP environment.
Risk management is a crucial part of the pharmaceutical quality management system. Unfraternally, many companies don’t get it right and don’t understand how to use ICH Q9 correctly. In this […]
In this podcast episode, Daniel Milek, a CSV expert from Data Integral Ltd, provides precious guidance on how you should go about your system validations.
In this podcast episode, Paul Palmer explains what types of deviations are there and how to deal with them successfully.
Working in a permanent job has its benefits, but also being an independent contractor or consultant. This work can be fantastic for many people who work in the pharmaceutical industry, […]
In this episode of The Qualitalks Podcast, Yan Kugel talked to Dr. Rhett Pascual, Ken Toley, and Dr. David Guy Brizan. They are the team responsible for CALIDAD.AI, a company […]
In this episode, Yan Kugel has interviewed Paul Palmer on how to prepare correctly for a regulatory GMP audit.
During his work in various pharmaceutical industry roles, Ammar Badwy has understood how difficult it is to find suppliers of raw materials that meet all the requirements. Therefore, Ammar has […]
Risk Management is a critical topic that is, unfortunately, misunderstood by many pharmaceutical companies. Many take the reactive approach instead of the proactive one, and that can cause them a […]
Digital transformation is the future of the pharmaceutical industry. Having an electronic quality management system (eQMS) in place means better efficiency, convenience, and compliance. However, the transformation is not a […]
The pharmaceutical industry is very lucrative and offers many employment possibilities. However, finding the right position for starting or advancing your career may present itself as challenging. To help you […]
Jennifer talks and gives practical advice on how to perform a successful supplier or internal audit from start to finish.
In this episode of the Qualitalks Podcast, you will learn how to prepare for audits as a GMP and a GxP auditor.
The manufacturing of sterile drugs is a critical and essential process. For the process to conform to the strict GMP requirement, it is crucial to design every aspect of the […]
Working in the pharmaceutical industry has its perk, as there are countless opportunities for career advancement. However, finding the right opportunities in the vast GMP world can be challenging. Therefore, […]
Building a successful career in pharma is complicated and requires specific tools, knowledge, and traits. But you can do it with any educational background if you have a healthy hunger […]
Today, most experienced pharmaceutical professionals want to become quality auditors, but they are not guided well or not having that much information about how to do it. By listening to […]
China is the most crucial supplier of chemicals to the pharmaceutical industry because it is not easy to find the alternatives that they have to offer. But there is a […]
Proper time management is essential for every worker in the pharmaceutical industry because many of the processes have strict deadlines. Not finishing tasks on time may lead to non-compliance.
In this episode, Yan Kugel talked to Dr. Michael Drues about medicinal combination products. Michael is an internationally recognized expert and featured keynote speaker on cutting edge medical technologies and […]
Due to the COVID-19 situation, governments across the world initiated lockdown and quarantines. The lockdowns have a severe impact on pharmaceutical manufacturing across the globe.
In this episode, Yan Kugel talked to José Sergio Ávila, a validation, and sterilization specialist, about validation activities in the pharmaceutical and medical devices industries.
Shoab Malek is a pharmaceutical consultant and a GMP auditor, located in India. Malek talked to Yan Kugel about the big challenges that India faces because of COVID-19. Being the […]
In this episode of the Qualitalks Podcast, Alex Hall and Yan Kugel discuss the crucial role of the Qualified Person in the pharmaceutical industry. Alex also provides great tips on […]
Paul Palmer and Yan Kugel talked about the quality assurance (QA) and Quality Control (QC) philosophy in organizations. Many companies don’t get it right, and it costs them in compliance, […]
