The Qualitalks Podcast Qualistery

In this episode, we welcome Jennifer Chang, a QA Intelligence Specialist at Blue Mountain. Yan Kugel and Jennifer discuss the impact of digital transformation on manufacturing processes, the challenges and benefits of compliance in the pharmaceutical industry, and companies' struggles in keeping up with regulators and taking a risk-based approach. They also explore why companies switch to digitized solutions and the importance of continuous learning in the pharmaceutical industry.

In this podcast episode, we had the pleasure of hosting Fabrizio Maniglio, an industry Business Development Director at Honeywell with a wealth of experience in Quality and Supply Chain Management within the life sciences sector. His insights into AI's transformative impact in the healthcare and pharmaceutical industries promise to make this conversation both enlightening and engaging.
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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.


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Podcast Overview:



The podcast episode features Fabrizio Maniglio, an experienced QA leader in the life sciences sector
He discusses the future of AI in pharmaceuticals and the importance of digitalization and connected data
The potential applications of AI in risk management and decision-making in the industry are highlighted
The FDA is moving towards a risk management validation approach for AI in regulated spaces
The discussion emphasizes the need for the pharma industry to drive change and not rely solely on regulators
Companies are encouraged to experiment with AI technologies in low-stakes scenarios and use AI as a tool to solve specific problems
The importance of staying current with AI trends and technology is emphasized, with recommendations for following the speaker on social media for more information on AI and potential future webinars.

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.

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