Preventing Alarm Fatigue in Life Science Facilities with EMS and Smart AI [Stephen Tierney]
Learn how continuous analytics, compliance, sustainability, and AI are reshaping water management in pharma manufacturing.
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Preventing Alarm Fatigue in Life Science Facilities with EMS and Smart AI [Stephen Tierney] Stephen Tierney
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Modernizing Pharmaceutical QC Laboratories: From Locked Data to AI‑Powered Decisions [Jon Welsh] Jon Welsh
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Reducing Risk and Costs: Continuous Water Quality Monitoring in Pharmaceutical Production [Konrad Sägesser] Konrad Sägesser
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Overcoming Tech Transfer Bottlenecks: From Paper Trails to Standardized Digital Hubs [Nikki Bishop] Nikki Bishop
Audits
Pharma Trends: The Return of the FDA Warning Letters [Simone Ammons]
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 […]
Navigating FDA Inspections: Things You Should Never Say! [Vincent F. Cafiso]
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 […]
Navigating the World of Asset Management and Quality Assurance [Jennifer Chang]
Join us for an insightful conversation with Jennifer, a quality assurance expert in the life sciences industry. Learn about the challenges and best practices in regulatory compliance and how continuous improvement is key in this ever-changing field. Gain valuable advice and insights for aspiring professionals looking to enter the industry.
What You Didn’t Know About FDA: Guide to Preparing Yourself for an FDA Audit
In this podcast, Luis Charles Chavarría shares his invaluable insights from his 30-year career in the FDA. He explains how the FDA really operates, their main purpose during an audit, and sheds light on details you have probably never known about the FDA.
The Golden Rules of Hosting an Audit
Apple PodcastsSpotifyYouTube In this podcast, Yan Kugel and our guest, Àngels Llarch, talk about how pharma companies should host external audits. Àngels shares some really insightful tips regarding hosting an audit, coming right from her 20 years of vast experience in the pharmaceutical industry. Who's Àngels Llarch? Currently working as [...]
How to Prepare Well for Regulatory Audits
In this episode, Yan Kugel has interviewed Paul Palmer on how to prepare correctly for a regulatory GMP audit.
How to Prepare for an Audit as a GxP Inspector
In this episode of the Qualitalks Podcast, you will learn how to prepare for audits as a GMP and a GxP auditor.
How To Build A Successful Career In Pharma With Any Education
Building a successful career in pharma is complicated and requires specific tools, knowledge, and traits. But you can do it with any educational background if you have a healthy hunger for knowledge. Jennifer Kussauer studied communication. Nonetheless, she built a fantastic pharma career and functioned as an Associate Director, Head of […]
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