{"version":1,"type":"rich","provider_name":"Libsyn","provider_url":"https:\/\/www.libsyn.com","height":90,"width":600,"title":"Episode 64: Compliance in the Biotech Industry with Paul Michel","description":"Welcome to Automating Quality, the life sciences\u2013focused show that bridges the gap between automation and quality management. In this episode, our host Philippe welcomes Paul Michel, Senior Consultant at SkillPad, with over 27 years of experience in the pharmaceutical and biopharmaceutical industries, including more than two decades in manufacturing. Paul specializes in GMP training, compliance readiness, and supporting organizations through the complexities of product development and commercial manufacturing. Together, they explore the realities of GxP compliance in biopharma manufacturing \u2014 from the scientific complexity of biologics and evolving regulatory expectations to the growing demand for specialized quality skills and the expanding role of CDMOs. The conversation highlights how automation, digital maturity, and strong quality foundations are becoming essential to sustain growth in this fast-evolving sector. &amp;nbsp; Key Takeaways 02:11 Why biologics manufacturing is fundamentally more complex than small molecule production 04:10 How living cell systems introduce variability and demand tight process control 05:29 Why scale-up in biomanufacturing is scientifically challenging and risk-prone 10:00 The role of ICH Q5 guidelines and comparability studies in biologics compliance 13:06 The growing demand for advanced quality skills in biologics and digital environments 17:18 How modern CDMOs enable faster development from DNA to IND through platform approaches 20:47 Why automation and digitalization are critical to closing the CDMO capacity gap &amp;nbsp; Contact Paul Michel on LinkedIn here: Paul Michel (He\/Him) | LinkedIn Contact us at solabs-podcast@solabs.com for questions or feedback! ","author_name":"Automating Quality","author_url":"https:\/\/docs.solabs.com\/hc\/en-us\/sections\/360006683193-Automating-Quality-Podcast","html":"<iframe title=\"Libsyn Player\" style=\"border: none\" src=\"\/\/html5-player.libsyn.com\/embed\/episode\/id\/40128600\/height\/90\/theme\/custom\/thumbnail\/yes\/direction\/forward\/render-playlist\/no\/custom-color\/88AA3C\/\" height=\"90\" width=\"600\" scrolling=\"no\"  allowfullscreen webkitallowfullscreen mozallowfullscreen oallowfullscreen msallowfullscreen><\/iframe>","thumbnail_url":"https:\/\/assets.libsyn.com\/secure\/item\/40128600"}