Developing Specifications for Drug Substances and Drug Products

This 2-day comprehensive course provides a broad overview of the process of establishing specifications through various development stages for drug products and drug substances made by synthesis or by conventional fermentation. The course focuses on the ICH approach for global harmonization. Using practical examples, the importance of understanding “real-life” constraints and regulatory requirements will be highlighted. Attendees will have the opportunity to participate in a hand-on-workshop to practice specification writing skills. The latest activities of the ICH and pharmacopeial harmonization relevant to setting specifications for drug substances and drug products are reviewed. Strategies for addressing Out-Of-Specification (OOS) findings will also be discussed. There will be opportunities to meet with the instructors and network with course participants. An open and interactive learning environment is encouraged throughout the course.