1. Designing experiments for validation of quantitative methods / T. Lynn Eudey -- 2. Validation of chemical reaction processes / Robert F. Dillard and Daniel R. Pilipauskas -- 3. The role of designed experiments in validation and process analytical technologies / Lynn D. Torbeck and Ronald C. Branning -- 4. Experimental design for bioassay development and validation / David M. Lansky -- 5. Use of experimental design techniques in the qualification and validation of plasma protein manufacturing processes / Sourav Kundu -- 6. Response surface methodology for validation of oral dosage forms / Thomas D. Murphy -- 7. The role of designed experiments in developing and validating control plans / Wayne A. Taylor -- 8. Efficient and effective process development work : the key to a successful validation study / Jeffrey T. Field.