Risk-Based Qualification of Sterile Drug Product Manufacturing Systems
March 29 - 31, 2016 - Bethesda MD USPDA
info@pda.org
Phone:301-656-5900
This new course is designed to teach students the techniques for effective qualification and validation of sterile drug product manufacturing systems. It will use a combination of lecture and hands-on application at the PDA Training and Research Institute and will make extensive use of the Aseptic Processing Suite. Instructors will walk students through the planning, protocol development, execution, and troubleshooting of the qualification of various drug product manufacturing systems, including critical utilities, formulation/compounding, component parts sterilization, filling, and packaging. Lectures and case studies will provide students the regulatory expectations, industry trends, and best practices for qualification and validation of sterile drug product manufacturing systems utilizing modern risk and science-based decision making approaches.