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

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

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 autoclave for your needs? How would you go about choosing a good vendor for autoclaves? What should go in the URA for autoclaves? What to check through all the qualification steps? What routine tests should you run on autoclaves daily? ------------------------------------------------------------------------------------------------------ Watch or read the full podcast and read the article at https://podcast.qualistery.com/how-to-choose-and-qualify-autoclaves-and-what-pitfalls-to-avoid ------------------------------------------------------------------------------------------------------ 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

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 this episode, Yan Kugel interviewed Philippe about the ever-changing excipient landscape and its role in drug manufacturing. Listing to the podcast, or watching the video, among others, you will learn about: What makes excipients such an exciting field How pharmaexcipients.com was born, and what is its purpose? Where is the excipient market heading? What should change in the excipient world? What can be achieved by choosing the most optimal excipient for the novel drug? ------------------------------------------------------------------------------------------------------ Watch or Listen to the full podcast and read the article at https://podcast.qualistery.com/how-is-the-excipient-world-evolving ------------------------------------------------------------------------------------------------------ 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

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 leaders don't know how to blend GMPs into their mission and vision with the right passion. Only then can employees see the whole vision and understand the "Why". Not just to do things because "it's required by the GMPs" but to see the value in those actions. Listening to the podcast or watching the clip, you will learn: How to establish a unified quality mission across a pharma organization Why some people see GxP as a hurdle, and how to change that Why using KPIs wrong can cost you your best employees How to Deliver Effective and Measurable GMP training ------------------------------------------------------------------------------------------------------ Watch or read the full podcast and read the article at https://podcast.qualistery.com/infusing-gxps-into-your-organizations-dna ------------------------------------------------------------------------------------------------------ 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

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 listening to or watching the podcast: · A new dawn for microbiologists in the pharmaceutical industry · What critical ideas Annex one introduces · What new roles will the Maintenance department, upper management, and operators will have · The importance of validating aseptic agents · How to start preparing for the Annex 1 launch ------------------------------------------------------------------------------------------------------ Watch or read the full podcast and read the article at https://podcast.qualistery.com/how-will-the-revised-annex-1-impact-your-contamination-control-strategy ------------------------------------------------------------------------------------------------------ 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

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 regulations in quality policies. With experience spanning 40 years, he is helping to develop coursework on manufacturing deviation investigations and teaching the course to enable the personnel to conduct and properly document investigations. ------------------------------------------------------------------------------------------------------ Watch or read the full podcast and read the article at https://podcast.qualistery.com/why-we-need-new-technology-in-gmp-and-what-stops-us ------------------------------------------------------------------------------------------------------ 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

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 he worked in product development, biosynthetic human insulin manufacturing, and site and corporate quality. At Redica Systems, Jerry works with the machine learning and data science teams. They build computer models that examine enforcement actions and produce analyses the way an expert would in the past using hard copy documents and a highlighter. He is also an author of many articles detailing and analyzing current hot topics among the pharma industry, and international regulators appear on the Redica Systems Conference Spotlight page. Listening to the podcast, you will learn about: ● The Evolution of Pharma Industry ● FDA Training Requirements ● Required Skills in Quality Domain ● Why Generalists are a Bad Thing ● Better Methods for Training Experts and Leaders ------------------------------------------------------------------------------------------------------ Watch or read the full podcast and read the article at www.podcast.qualistery.com/things-that-have-to-change-in-gmp-to-drive-success ------------------------------------------------------------------------------------------------------ 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

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 Manager at Headcount AG. It is a Zürich based consultancy serving clients in the pharmaceutical and biotechnology market segments. Megan has been working as a recruiter for six years, specializing in Pharma since the very start of her career. She is now building up her team within headcount and embracing management responsibilities and technical operations positions. Listening to the Podcast, You Will Learn About: ● Innovations in the Pharmaceutical Industry ● Effect of New Developments on Recruiting Process ● Challenges for the New People in the Industry ● What Are Pharmaceutical Companies Looking for? ------------------------------------------------------------------------------------------------------ Watch or read the full podcast and read the article at www.podcast.qualistery.com/how-to-build-a-successful-career-in-the-pharma-of-tomorrow ------------------------------------------------------------------------------------------------------ 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

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 International. He has also worked with the US Department of Justice and contributed to policymaking at the national as well as on the international level. Reading the Article and Listening to the Podcast, You Will Learn About: ● What Does an FDA Agent Do? ● Difference Between an FDA Investigator and a Regular Quality Auditor ● Evidence Development by an FDA Investigator ● Procedures for Foreign-Based Manufacturing Units ------------------------------------------------------------------------------------------------------ Watch or read the full podcast and read the article at www.podcast.qualistery.com/guide-to-preparing-yourself-for-an-fda-audit/ ------------------------------------------------------------------------------------------------------ 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