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Validation

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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 […]

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Computer System Validation

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 […]

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Enhancing Compliance and Efficiency in Pharma Manufacturing with AI [Vivek Gera]

Vivek Gera June 19, 2024

Vivek shared his wealth of experience leveraging cutting-edge technologies to enhance compliance and operational efficiency within the pharmaceutical manufacturing industry. Throughout the episode, Vivek delved 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 […]

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How to Navigate GDP Compliance in Pharma [Paul Sarrazin]

Paul Sarrazin June 5, 2024

Paul shares his wealth of experience and insights into innovative strategies and best practices for maintaining quality standards and regulatory compliance in the pharmaceutical supply chain. The discussion delves into the evolving landscape of GDP and the key insights gained from Paul’s recent projects in the industry. The conversation also […]