Episode Archive - The Qualitalks Podcast

Yan Kugel is joined by Will Moss founder and CEO of Seal, to talk 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. The Need for Automation in GXP Processes Will Moss’s journey into the pharmaceutical industry began with a simple realization: the GXP industry is ripe for automation. With a background in chemical engineering from Cambridge University, Will transitioned into data science and software engineering before founding Seal nearly six years ago. His goal? To help […]

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Navigating Workplace Dynamics as a Woman in Leadership [Christy Mazzarisi]

Christy Mazzarisi August 28, 2024

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. Meet Christy Mazzarisi Christy Mazzarisi has been in the life sciences space for about 20 years, working in various quality roles within the pharmaceutical industry. She shares her journey from starting in the laboratory to leading quality and clinical teams at Network Partners Group. Her experiences have shaped her approach […]

Featured

Pharma Trends: The Return of the FDA Warning Letters [Simone Ammons]

Simone (George) Ammons August 21, 2024

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 QuneUp, 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. Simone’s Career Journey Simone shares her career journey, from starting in chemical engineering to transitioning into the pharmaceutical industry. She discusses her experiences in the oil and gas industry and how she ultimately found her passion in pharma. Simone […]

Biomanufacturing

The Impact of AI on Patent Research and Analysis in the Pharma [Ben Coverdale]

Ben Coverdale August 14, 2024

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. The Role of AI and LLMs in Patent Research AI and LLMs are revolutionizing patent research and analysis in the pharmaceutical industry. These advanced technologies are enabling companies to navigate the complexities of the patent landscape, extract key data points from patents, and drive advancements in […]

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Navigating Complexity: Challenges and Solutions in Pharma 4.0 [Pavan Pasupulati]

Pavan Pasupulati August 7, 2024

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. The Role of Electronic Batch Records Pavan emphasized the significance of electronic batch records in the pharmaceutical manufacturing process, highlighting the benefits of automation and digital solutions in improving productivity, reducing manual errors, and ensuring data integrity. As the crux of the entire manufacturing process, electronic batch […]

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Navigating FDA Inspections: Things You Should Never Say! [Vincent F. Cafiso]

Vincent F. Cafiso July 31, 2024

Yan Kugel is joined by Vincent 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. Vincent’s Background as an FDA Investigator Vincent brings a wealth of experience to the table, having worked as an FDA investigator for six years. His passion for science and his deep knowledge of the pharmaceutical and medical device industry have allowed him to conduct hundreds of complex inspections, both domestically and overseas. His insights into […]

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The Strategic Journey of Pharmaceutical Commercialization [Mohamed Amer]

Mohamed Amer July 24, 2024

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. The Importance of CME Accreditation Mohamed emphasizes the significance of CME (Continuing Medical Education) accreditation when promoting pharmaceutical products. This accreditation is a major attraction for healthcare professionals attending events and conferences. It demonstrates that the material and lectures provided are CME […]

Quality

Improving Processes: Insights and Transitions [Kelly Stanton]

Kelly Stanton July 17, 2024

In this episode, Kelly discusses her experiences in the pharmaceutical industry and the challenges of implementing cloud-based software tools. She also shares insights on improving processes and the impact it has on an organization.

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Revolutionizing Validation and Automation in Biotech [Nagesh Nama]

Nagesh Nama July 10, 2024

In this podcast episode, Nagesh Nama shares his expertise in incorporating AI into validated processes within the pharmaceutical industry. He discusses the benefits, challenges, and best practices of using AI and machine learning technologies in pharmaceutical manufacturing quality.

Featured

Navigating Communication Challenges in Quality-Driven Environments [Lesley Worthington]

Lesley Worthington July 3, 2024

Yan Kugel is joined by Lesley Worthington, a communication and leadership coach for quality professionals, to discuss the importance of interpersonal skills in quality assurance within the pharmaceutical industry. Lesley highlights the often overlooked yet crucial role of communication and interpersonal skills in the success of quality professionals, emphasizing the need for a balance between technical knowledge and interpersonal abilities.