- How to Write Standard Operating Procedures and Work Instructions.2nd Edition: A Handbook for Quality Managers and Quality Engineers.
- Principles of Process validation: A handbook for professionals in Medical Device, Pharmaceutical, and Biomedical Industries.
- How to Design a World-Class Corrective Action Preventive Action System for FDA-Regulated Industries: A Handbook for Quality Engineers and Quality Mana
- Principles of Change Control: A Handbook for Quality and Regulatory Professionals
- Designing A World-Class Quality Management System For FDA Regulated Industries: Quality System Requirements (QSR) For cGMP









