The Qualitalks Podcast Qualistery

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?


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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.

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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

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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!

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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/

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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.

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Watch or read the full podcast and read the article at: https://podcast.qualistery.com/steps-to-validating-a-temperature-controlled-chamber-nathan-roman

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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!

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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/

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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?

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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

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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