020- "The Right Words" with Kathy Walsh
Dr. Kathy Walsh, Director and Principal at Quality Systems Now, explains how to write plain language procedures for regulated industries, drawing on her book 'Eliminating the Gobbledygook'. She details techniques such as process mapping, inference building, sentence parsing, and active voice to reduce FDA 483 observations related to documentation. Walsh emphasizes that document design, including font choice and structure, is critical for comprehension and compliance, arguing that clear writing is a civil right and a core component of effective quality management systems.