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 ..read more

Yogesh Krishan Davé has been working in the pharmaceutical industry for more than 40 years now. He is an EU Qualified Person and a consultant. During this long time, Yogesh has encountered many deficiencies from which most pharma companies suffer. In this podcast, Yogesh has addressed deficiencies in two systems and explained how to tackle them: 1. Training 2. Deviations and CAPA handling Here are some of the things that you will learn about in the podcast: ? Training - One of the Biggest Deficiencies in the Pharma Industry ? How to Motivate People Outside of QA to Be Part of the  Organ ..read more

In this episode of the Qualitalks Podcast, Alex Hall and Yan Kugel discussed Risk Management in the pharmaceutical industry. Risk Management is a critical topic that is, unfortunately, misunderstood by many pharmaceutical companies. Many take the reactive approach instead of the proactive one, which can cause them a lot of money and risk customer lives. Any decision–making process about risks to product quality involves risk management to a greater or lesser extent. Here are some of the things that we can learn in the pharma industry about Risk Management: 1. What is the definition of Risk? 2 ..read more

In this episode of the Qualitalks Podcast, our guest is Jennifer Kussauer, a senior international GxP auditor. Jennifer talks and gives practical advice on how to perform a successful supplier or internal audit from start to finish.  Here are some of the topics we covered in our talk: ?01 Secrets to a Successful Audit Opening Meeting ?02 Here Is When Repeated Deviations Are Acceptable ?03 Why Time Good Time Management Skill Is Important for Auditors ?04 Here Are the Most Common Mistakes That Companies Do- ?05 Here Is an Important Message for Auditees- ?06  How to Write a Good and Us ..read more

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 ..read more

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 ..read more

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-c ..read more

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 Sci ..read more

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 ..read more

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 fo ..read more