The Qualitalks Podcast

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.

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.

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

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.

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.

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 pr

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 rega

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 o

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 so

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