The Qualitalks Podcast

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 GMP environments and the challenges they pose for the industry. Plus, we will explore how MyCellHub’s toolkit is revolutionizing the biomanufacturing process by improving quality compliance and production times. Finally, we’ll shift gears towards Toon’s thoughts on the ever-evolving pharma industry amidst global events such as COVID-19. How will digitalization and data integration play a role in shaping the future of pharmaceuticals? --------------------------------------- You can watch the video episode here. Learn more about GMP by joining our free educational webinars at www.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

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 preparation. In addition, Nathan discusses the evolution of qualification protocols, including the incorporation of paperless validation and the need to stay up-to-date with new technologies. Listening to the podcast, or watching the video, among others, you will learn about: -What is a qualification protocol?  -When should you have it ready?  -What are the prerequisites?  -What should it include?  -And what are some common problems?  Make sure you don't skip this enlightening and captivating dialogue. Listen in immediately!  ---------------------------------------------------------------------------------------- Watch or read the full podcast and read the article at: https://podcast.qualistery.com/temperature-mapping-all-you-need-to-know-about-good-qualification-protocol-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

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 Roman, one of the top experts in Temperature control mapping who help people in the Health & Life Science industry learn how to implement and carry out temperature mapping studies and equipment qualifications (IQ, OQ, PQ). Listing to the podcast, or watching the video, among others, you will learn about: What are temperature mapping studies, and why are they so critical for pharmaceutical compliance? Where is thermal mapping required, and why? What is the process for a temperature mapping study? What is the most challenging part of your job? What do most people do wrong with thermal mapping, and what would be your suggestion to improve? What resources can help pharma professionals stay updated with the latest regulations and trends? So tune in to learn all there is to know about thermal mapping and its impact on pharmaceutical compliance! ------------------------------------------------------------------------------------------------------ Watch or read the full podcast and read the article at: https://podcast.qualistery.com/what-is-thermal-mapping-and-why-its-so-important-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

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 regulatory affairs. Listening to the podcast and reading the article, you will learn: What is a combination product? What are some examples of combination products? What are the roles of the Office of Combination Products? How are combination products assigned for review? What types of marketing applications are required for a combination product? How are adverse events reported for combination products? A Three-Step Path toward Combination Product Approval Challenges with Combination Products Watch the video talk on Qualistery.com

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. Some of that include: Shortage of raw materials Personnel deficiency Export bans Severe financial damage All those obstacles lead to a unique manufacturing environment, which may lead to quality deficiencies. During their talk, Hitendrakumar Shah, the CEO of NADH+ GXP Compliance Services, shared with Yan Kugel his suggestions on how to avoid quality issues during manufacturing, throughout that particular time. You can watch the podcast in a video format on www.qualistery.com

In this episode, Yan Kugel talks to José Sergio Ávila, a validation, and sterilization specialist, about validation activities in the pharmaceutical and medical devices industries. We covered several topics with Sergio: EtO sterilization Importance of purified water systems and validation challenges Validation of medical devices and the differences to pharmaceutical validation How to stay current with the new regulation in the quickly developing field of validation Biggest mistakes people do when they perform validations The Key for successful validations Tips for becoming experts in the field Watch the video and read the article- here.

Shoab Malek is a pharmaceutical consultant and a GMP auditor, located in India. He talked to Yan Kugel about the big challenges that India faces because of COVID-19. Being the biggest generic pharmaceutical exporter in the world, it may influence the whole world. The prices in India for many drugs have already doubled or tripled, for many reasons: Raw material shortage Packaging material shortage Shortage of skilled workers Not enough storage places for finished goods The supply chain to the rest of the world has completely stopped The videocast is available on www.qualistery.com

In this episode of the Qualitalks Podcast, Alex Hall and I discuss the most crucial role of the Qualified Person in the pharmaceutical industry. Listening to the podcats and reading the article, you will learn: About the role of the Qualified Person (QP) in the European Union The difference between a QP and a quality manager Who should consider becoming a QP The legal requirements for becoming a QP What soft skills are required to become a QP Tips for success in becoming a QP Watch the video: www.qualistery.com

Paul Palmer and I 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, time, and money. But it is not too late for any company to change that. In the podcast/article, you will learn: What QA philosophy is What benefits QA philosophy holds How to implement the QA Philosophy across the organization What mistakes to avoid when looking at trend analysis Why and how to choose consultants to support you

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.

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 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.

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 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.

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, 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.

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 Nagesh Nama, CEO at xLM who brings a wealth of experience and expertise in incorporating AI into validated processes within the pharmaceutical industry. Nagesh shares insights on the benefit challenges and best practices of using AI and machine learning technologies in pharmaceutical manufacturing quality. His insights shed light on the challenges and solutions in implementing AI in pharmaceutical manufacturing quality. The potential for AI to improve efficiency, reduce costs, and enhance regulatory compliance is evident, and the future of AI in pharma looks promising.