This book is based on a three-day course taught by the author and his colleague that is designed for all scientists (managerial and laboratory) whose job function necessitates the generation, evaluation and assurance of data that will be incorporated in regulatory filings with the FDA and similar European organizations. The book also provides readers with an understanding of terminology and acceptable practices for laboratory studies and the role GLPs play in assuring the validity of these studies, and helps readers develop an understanding of the needs for thorough documentation.