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Episodios
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In this episode, Yan Kugel is joined by Will Moss founder and CEO of Seal, about the critical need for automation in GXP processes. Will shares his expertise on balancing automation with human oversight, addressing data privacy concerns, and the future of quality management in the pharmaceutical sector.
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In this episode, Yan Kugel is joined by Christy Mazzarisi, a distinguished leader in the pharmaceutical industry with extensive experience in quality systems and leadership roles. In this episode, we explore Christy's journey in pharma, her works, her impact on advocacy and leadership, and her vision for empowering women in the pharmaceutical industry.
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In this episode, Yan Kugel is joined by Simone Ammons, a dynamic engineer, technical writer, and entrepreneur who has navigated through diverse industries with finesse. She's the founder of the QneUp, a data-driven software tool that reduces equipment downtime and boosts productivity in the pharmaceutical industry. In this episode, we will be discussing data and FDA warning letters trends across the years with Simone.
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In this episode, Yan Kugel is joined by Ben Coverdale, PhD, a seasoned global account director at Patsnap with a strong background in the life sciences and innovation and intelligence sectors. Ben brings a wealth of experience and insights into how AI and LLMs (Large Language Models) are transforming patent research and analysis in the pharmaceutical industry.
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Yan Kugel is joined by Pavan Pasupulati, the Vice President of Manufacturing Excellence at Caliber Technologies.
Here, he shares valuable insights into the future of pharmaceutical manufacturing. With over 25 years of experience in both the process and IT industries, Pavan has become a key figure in driving digital transformation within pharmaceutical manufacturing.
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Yan Kugel is joined by Vincent F. Cafiso, the Director of Quality and Regulatory Services at CREO Consultancy and a former FDA investigator. Vincent shares invaluable advice on things never to say to an FDA investigator based on his extensive experience and expertise in the field. Join us as we uncover essential strategies and best practices to navigate FDA inspections with professionalism, compliance, and a proactive mindset.
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In this episode, Yan Kugel is joined by Mohamed Amer, a seasoned executive with over 20 years of experience in strategic and commercial leadership in the healthcare industry. Mohamed emphasizes the significance of CME (Continuing Medical Education) accreditation when promoting pharmaceutical products. He further discusses the challenges companies face in different countries regarding ethical standards and regulations when promoting pharmaceutical products.
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In this episode we are joined by Kelly Stanton, the Head of Quality Systems Improvement at Corden Pharma. Kelly discusses her transition back to the pharmaceutical industry after four years at Qualio, an eQMS provider. She also shares her improvement projects that make a real difference in her organization. Additionally, she shares insights on improving processes, the importance of regulatory compliance, and the impact of implementing changes within an organization. The conversation also delves into the benefits of using automated tools, making processes lean, and the significance of leveraging electronic tools to improve efficiency. Tune in to gain valuable insights into the pharmaceutical industry and the importance of continuous improvement in processes.
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Yan Kugel is joined by Nagesh Nama, CEO at xLM who brings a wealth of experience and expertise in incorporating AI into validated processes within the pharmaceutical industry. Nagesh shares insights on the benefit challenges and best practices of using AI and machine learning technologies in pharmaceutical manufacturing quality.His insights shed light on the challenges and solutions in implementing AI in pharmaceutical manufacturing quality. The potential for AI to improve efficiency, reduce costs, and enhance regulatory compliance is evident, and the future of AI in pharma looks promising.
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Yan Kugel is joined by Lesley Worthington, a communication and leadership coach for quality professionals. Together, they discussed the significance of interpersonal skills in the realm of quality assurance within the pharmaceutical industry.Lesley emphasizes that communication and interpersonal skills are often overlooked but are crucial for quality professionals. Technical knowledge is important, but it must be balanced with strong interpersonal skills to excel in the quality assurance field.
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In this episode, we will delve into the future of pharma and explore the intersection of AI, ML, and GMP compliance. Today, we are thrilled to have Vasyl Chumachenko, head of AI consulting at Data Science UA, join us as our esteemed guest. With a wealth of experience in integrating AI solutions into chemical and pharmaceuticals, Vasil brings a unique perspective on driving innovation and growth in the industry.
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In today's episode, our guest is Vivek Gera, the CEO of Leucine and a seasoned process engineer. Vivek has a wealth of experience leveraging cutting-edge technologies to enhance compliance and operational efficiency within pharmaceutical manufacturing. Throughout this episode, we will delve into the transformative impact of AI on manufacturing, QA, and QC processes, shedding light on how these advancements are revolutionizing productivity and adherence to CGMP guidelines.
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Yan Kugel is joined by Jakob Konradsen, the Co-Founder & Head of Quality at Eupry and here he discusses the importance of moving away from paper or PDF calibration certificates and manual work in the GXP industry.They explore the idea of using machine learning algorithms for auditing and the need for a business continuity plan for temperature control. The speaker emphasizes the value of being prepared for potential issues and encourages professionals to focus on improving emergency response plans. The episode ends with a recommendation to connect with the speaker on LinkedIn for further discussions on temperature control.
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Yan Kugel is joined by Paul Sarrazin, an esteemed expert in good distribution practices (GDP) within the pharmaceutical sector. Here, he provides a glimpse into his journey from a permanent employee to a consultant specializing in GDP compliance. With a strong background in bioengineering and a rich portfolio of collaborations with industry giants like GSK, UCB, and Takeda, Paul's expertise in GDPs is rooted in his early consulting career and subsequent roles within pharmaceutical companies.Paul sheds light on the advantages of being a consultant in the pharmaceutical industry, emphasizing the autonomy and diversity of projects that come with the role.
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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.
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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.------------------------------------------------------
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 [email protected].
------------------------------------------------------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 [email protected].
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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 [email protected].
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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.
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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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