Antonio Burazer
Global Head Visual Inspection & Particle Life Cycle Management
Antonio Burazer is a seasoned pharmaceutical leader with over 15 years of experience seamlessly integrating operational manufacturing and global quality. He managed visual inspection and secondary packaging processes at a multi-product manufacturing facility in Vienna, Austria, before transitioning to a global quality leadership role. As the Global Head for Visual Inspection and Particle Life Cycle Management at Takeda, Antonio spearheaded the development and implementation of an enterprise-wide program that reduced particle-related issues by 90%, while improving compliance and harmonization across internal manufacturing sites and CDMOs. Actively engaged with industry associations, he shares his expertise to drive innovation and deliver impactful solutions that enhance patient outcomes worldwide.
DAY 1: June 5th, 2025
SESSION: Regulatory and Compendial Requirements for Visual Inspection
◆ Review of global regulations (FDA, EMA, ICH, GMP Annex 1) regarding visual inspection.
◆ Key compendial standards (USP <790>, USP <1790>, Ph. Eur., JP).
◆ Responsibilities of manufacturers for compliance with visual inspection guidelines.
SESSION: Lifecycle Approach in Visual Inspection and Particle Management
◆ Overview of the lifecycle of visual inspection systems in parenteral drug products.
◆ Lifecycle management of visible particulate matter: industry best practices.
◆ 100% Inspection vs. 100% Detection
