This podcast episode features Dr. Mohamad Toutounji, founder of Molgenium, a firm specializing in pharmaceutical quality and regulatory compliance. The discussion centers on preparing for FDA inspections and ensuring a Quality Management System (QMS) is robust and compliant. Dr. Toutounji shares his extensive experience, offering practical advice on identifying and remediating QMS gaps before an inspection, handling common challenges like SOP and CAPA backlogs, and emphasizes the importance of staff preparation and transparency during the inspection process. He also discusses key documents inspectors typically request and how to manage findings, ultimately highlighting that an effective QMS focuses on consistent product quality and patient safety.