ch. 1. Guidelines to process validation / Gail Sofer -- ch. 2. Commentary on the US Food and Drug Administration's 2011 Guidance for industry, process validation general principles and practices / Hal Baseman -- ch. 3. Applications of failure modes and effects analysis to biotechnology manufacturing processes / Robert J. Seely and John Haury -- ch. 4. Process characterization / James E. Seely -- ch. 5. Scaled-down models for purification processes : approaches and applications / Ranga Godavarti. [et al.] -- ch. 6. Adventitious agents : concerns and testing for biopharmaceuticals / Raymond W. Nims. [et al.] -- ch. 7. Lifespan studies for chromatography and filtration media / Anurag S. Rathore and Gail Sofer -- ch. 8. Validation of a filtration step / Jennifer Campbell -- ch. 9. Analytical test methods for well-characterized biological and biotechnological products / Nadine Ritter and John McEntire -- ch. 10. Facility design issues : a regulatory perspective / Susan Vargo and Nancy Kavanaugh -- ch. 11. Validation of computerized systems / Monica J. Cahilly -- ch. 12. Process validation with a CMO / Susan Dana Jones, Sheila G. Magil, and Gail Sofer -- ch. 13. Risk management and validation / James Agalloco -- ch. 14. Process validation in membrane chromatography / Suma Ray and Miyako Hirai -- ch. 15. Leveraging multivariate analysis tools to qualify scaled-down models / John Pieracci and Helena Yusuf-Makagiansar -- ch. 16. Process validation of a multivalent bacterial vaccine : a novel matrix approach / Narahari S. Pujar. [et al.] -- ch. 17. Validation of the Zevalin purification process : a case study / Lynn Conley, John McPherson, and Jorg Thommes -- ch. 18. Viral clearance validation : a case study / Michael Rubino. [et al.].