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 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...

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...

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...

One of the most common concerns in GxP quality is maintaining the temperature of laboratory and manufacturing storage environments. Temperature Mapping, also known as thermal mapping, is an activity performed on temperature-controlled chambers often used to track temperature changes within the storage space over a long period. This podcast episode focuses on the importance of temperature mapping studies and why they are so critical for pharmaceutical compliance. Our guest speaker is Nathan...

Steve Galen has been involved in clinical trials for more than 27 years now, in various high-level positions. In this podcast episode, he will explain the different stages of the clinical trials and point out the most severe deficiencies in the industry and how to overcome there. By listening to this episode of watching it, you will learn about: What is a clinical trial, and what's the main goal? What are the questions asked in clinical trials protocols? What are the parts of a clinical...

In this podcast episode, our guest is Chris Maughan, a Sterilisation and Validation Consultant.  Chris has spanned over 16 years with areas of expertise including validation compliance and consultancy support and training across Europe, the Middle East, Asia and the USA. In this episode, you will learn about: What is the role of autoclave sterilization in the pharmaceutical industry? What are some of the significant types of autoclaves in the market? How to choose an...

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 the drug's function. In this podcast episode, our guest is Philippe Tschopp. Philippe is a Business Developer at Glatt Pharma and an enormous Excipient enthusiast. Because of his passion, he found the website www.pharmaexcipients.com, where they post scientific insights about developments in the excipient world. 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 Compliance Insight, Inc. They help businesses overseen by the FDA navigate the regulatory process, achieve compliance, and develop best practices for manufacturing innovative drugs, medical devices, and biologics. Troy believes that the single most challenging issue leaders face is incorporating GMPs into their company culture. The...

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 and disinfection. During their talk, Marc discussed with Yan Kugel about the EU GMP Annex 1 Revision: Manufacture of Sterile Medicinal Products draft and how it would affect pharma companies and their current contamination strategies. Here are some of the things you'll learn about...

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 same. In this episode, they discuss technological advancement in the pharmaceutical industry, what holds us back, and where we are headed. Who is Jerry Chapman? Currently working as Senior GMP Quality Expert at Redica Systems, Jerry has invaluable experience in the quality domain and implementation of international GMP...

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 the years and what has remained the same. He discusses the development of new courses as well as the importance of leadership training in the companies. Who is Jerry Chapman? Jerry Chapman is Senior GMP Quality Expert at Redica Systems. He brings over 40 years of experience in the pharma industry, including 31 years at Eli Lilly, where...

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 companies are looking for. Her experience in the recruitment field enables her to give valuable insights that will potentially help you to build a successful career in the future. Who Is Megan Löffler? With an educational background in engineering coupled with an HR degree, Megann is currently working as a Talent Acquisition...

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, and sheds light on details you have probably never known about the FDA.  Who Is Luis Charles Chavarría? Luis has served in FDA for about three decades in several capacities that have earned him an unprecedented understanding of FDA affairs. He is currently working as President/Lead Consultant at Supaso...

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 future and the role of Artificial Intelligence and Personalized Medicine in disease treatment and the future of medicine. We will also ask Dr. Leyfman about some of his extraordinary career and life experiences. Who Is Yan Leyfman? Yan Leyfman, MD, is a medical doctor and a passionate researcher. His areas of command and interest...

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 about them as a startup, a company, or just as an individual.  Our highly experienced and knowledgeable guest for this session is Kurt in Albon. Kurt is Global Head of Information Quality at Lonza, one of the biggest CMOs in the world. He has been in the pharmaceutical industry for more than 25 years and...

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 discuss using LinkedIn marketing to grow a robust business network as a pharma company, business, or independent entity. Who Is Rizgar Saltik? Currently working as a partner and consultant at Sciential, Rizgar is life sciences and health entrepreneur specializing in Digital Marketing and...

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 are required to be a successful leader, what pharma companies should look for when hiring talent, and some valuable tips for people who aspire leadership. Who is Kurt In Albon? Kurt is Global Head of Information Quality at Lonza, one of the biggest CMOs in the world. He has been in the pharmaceutical industry for over...

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 customer should look for in them. We’ll also ask him about Glatt Group as an example of how CMDOs work. Who is Philippe Tschopp? Philippe is the head of business development at Glatt Pharmaceutical Services. He has solid experience of well over a decade in business, sales and B2B digital marketing. He is also...

In this podcast, Yan Kugel and our guest, Àngels Llarch, talk about how pharma companies should host external audits. Àngels shares some really insightful tips regarding hosting an audit, coming right from her 20 years of vast experience in the pharmaceutical industry. Who's Àngels Llarch? Currently working as API Compliance Head/Deputy RP at IMCD Switzerland AG, Àngels has more than two decades of solid experience, working in the Quality domain for several renowned pharmaceutical suppliers....

Christy Mazzarisi is the Global Lead of Quality at CGI, supporting clients with automation quality systems. In this episode, Christy talks to Yan Kugel and sheds light on the complex world of pharmaceutical automation and AI. Listening to or watching this Qualitalks Podcast episode, you will learn about: What is the difference between intelligent automation (IA) and Artificial Intelligence (AI)? What is the value of AI and IA to pharmaceutical quality? How much money, time, and...

Yuval Shapiro is the founder of Quality with Value Ltd. A company that provides QA/RA for Medical Devices Services. Yuval is a Quality Assurance & Regulatory Affairs Expert and consultant for products and companies primarily related to medical devices and telecom sectors. Additionally, he is a black belt Six Sigma certified from Johnson & Johnson.  In this podcast episode, he discusses with Yan Kugel the history and evolution of Quality and why we are witnessing the death of Quality...

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 job by Roche to become an independent consultant. She also reveals what the REAL job of the consultant is, what the challenges are behind it, and gives advice for employers for making the best of their consultants. Watch the full video episode here.

James Ainsworth is a software developer who started supporting businesses with ERP deployment and CSV about ten years ago. Besides the pharmaceutical and biotech sectors, James has experience consulting companies in other highly regulated industries such as Automotive and Fintech. In this podcast episode, James spoke to Yan Kugel about CSV and its essential parts, about which you don't learn in training. Here are some of the topics you will hear about: The most challenging parts of CSV...