Manufacturing “quality by design”
Executive Summary
FDA's Pharmaceutical Science Advisory Committee/Manufacturing Subcommittee will discuss "quality by design" approaches and how they contrast to approaches that test-in quality during a Sept. 17 meeting. On Sept. 18 the subcommittee will discuss and define principles by which risk management is integrated into decision making. The meeting will begin at 8:30 a.m. at 5630 Fishers Lane, Rockville, Md. both days...