The Qualitalks Podcast

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 the drug lifecycle to accelerate discovery, scale manufacturing, and ensure compliant release. Our analytical and process technologies support pharmaceutical and biotech teams from research and formulation through commercial manufacturing and quality control. With integrated instrumentation, workflow solutions, and expert service, we help protect yield, ensure data integrity, and deliver therapies to patients with confidence.----------------------Visit ⁠www.qualistery.com⁠ for live free webinars for GxP professionals, to stay on top of the latest industry trends.

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.

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.

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.

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.

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.

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.

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.

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 the autonomy and diversity of projects that come with the role.

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 companies looking to connect and do business. Episode Chapters: Introduction and background (0:00 - 2:45) Changes and trends in the API market (2:46 - 8:30) Insights from analytics and understanding market needs (8:31 - 15:22) Focus on the contract services market (15:23 - 19:40) Acceptance of data sharing and challenges (19:41 - 25:10) Connecting service providers in the pharma industry (25:11 - 30:45) Conclusion and future plans (30:46 - 34:20) The podcast is brought to you by Qualistery, a leading provider of webinars, training, and consulting for the pharma industry. For business inquiries, get in touch at info@qualistery.com.

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 your purpose should be based on your criteria, such as cost, electricity, and safety. The conversation also covers the need to ensure that products arrive safely in the first mile of the supply chain and how to ensure that temperature-sensitive goods are transported, handled, and stored properly. Tune in now to better understand cold chain solutions, how to monitor them, and how they can help you in your industry. ------------------------------------------------------------------------------------------------------ Watch or read the full podcast and read the article at: https://podcast.qualistery.com/what-cold-chain-solutions-are-there-and-how-to-monitor-them-nathan-roman ------------------------------------------------------------------------------------------------------ This episode is sponsored by Eupry, a provider of state-of-the-art environmental monitoring systems. Eupry supports the further development of a host of industries, including Laboratory, Pharmacy, Healthcare, Pharma, Food, and more, by providing efficient solutions to monitor temperature-sensitive assets. Join us on our webinars and visit our website for more GMP insights, tips, and resources. Don't miss out - follow Qualistery today! #Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

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 Chamber is, and why are those needed? What types of temperature-controlled chambers are available, Which regulations exist, which steps of the validation process are most challenging, What common mistakes during the validation to avoid? Plus, get recommendations for resources to stay current with regulations and best practices. ----------------------------------------------------------------------------------------------------- Watch or read the full podcast and read the article at: https://podcast.qualistery.com/steps-to-validating-a-temperature-controlled-chamber-nathan-roman ------------------------------------------------------------------------------------------------------ This episode is Sponsored by Eupry, a provider of state-of-the-art environmental monitoring systems. Eupry supports the further development of a host of industries, including Laboratory, Pharmacy, Healthcare, Pharma, Food, and more, by providing efficient solutions to monitor temperature-sensitive assets. Join us on our webinars and visit our website for more GMP insights, tips, and resources. Don't miss out - follow Qualistery today! #Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

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 trial? How are those parts connected to the primary goal? What are the most common challenges with clinical trials nowadays? How can we make clinical trials more transparent and predictable? What are the goals of VC-funded biotech in early-stage clinical development versus pharma in later-stage clinical development, and how are these goals related to the primary purpose of a clinical trial? ------------------------------------------------------------------------------------------------------ Watch or read the full podcast and read the article at https://podcast.qualistery.com/what-are-clinical-trials-and-and-how-to-solve-its-biggest-challenges ------------------------------------------------------------------------------------------------------ This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier. #Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing