The Qualitalks Podcast Qualistery

In today's episode, we have a special guest, Harsh Thakkar, who has made a successful journey into consulting within the pharmaceutical industry. Harsh is a seasoned professional with extensive experience in advising on GXP practices and regulatory compliance. His career in consulting in the life science field is filled with insights, challenges, and triumphs that have shaped his career and made him a respected figure in the industry.



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.

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 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