Quality

Dr. Kate McCormick is a pharmaceutical manufacturing consultant and trainer who has worked extensively with both regulators and companies in more than 50 countries. She is the author of a number of textbooks, and she was an editor of GMP Review and International Education Advisor for ISPE. Dr. McCormick has a degree in biochemistry, a doctorate in microbiology, and is also a Master of Business Administration. Janet H. Sanders is an Associate Professor in the Department of Technology Systems at East Carolina University where her research focus includes quality, statistics, Lean Six Sigma, and process improvement methodologies. She has a BS in Ceramic Engineering, MS in Industrial Management, and a PhD in Industrial Engineering, and 30+ years of process improvement experience in various manufacturing, service, and healthcare industries.

1. Product Life Cycle 2. Good Manufacturing Practice 3. Elements of Quality Management 4. Quality Systems and International Standards 5. The Management of Quality 6. Inspections and Auditing 7. Quality Improvement Programmes 8. Corrective and preventive actions 9. Calibration 10. Validation 11. Technology Transfer 12. Water for Pharmaceutical Use 13. Pharmaceutical Microbiology 14. Good Distribution Practice