• 1. The Basics of Good Manufacturing Practice
• 2. Regulatory Overview
• 3. Personnel Matters
• 4. Physical Plant and Grounds
• 5. Equipment and Utensils
• 6. Cleaning and Sanitation
• 7. Maintenance and GMP
• 8. Calibration
• 9. Production and Process Controls
• 10. Specifications
• 11. Sampling
• 12. Deviations and Corrective Actions
• 13. Incoming Components, Packaging Materials and Labels
• 14. Master Manufacturing Record
• 15. Batch Production Record
• 16. Manufacturing Operations
• 17. Packaging and Labeling Operations
• 18. Quality Control Responsibilities
• 19. Laboratory Operations
• 20. Returned Goods
• 21. Product Complaint Handling
• 22. Holding and Distributing
• 23. Handling Recalls
• 24. Top Management Responsibility
• 25. Record Keeping, Documentation, SOPs
• 26, Change Control
• 27. Adverse Event Reporting and Records Keeping
• 28. Continuous Improvement
• 29. Supply Chain Integrity
• 30. Audits
• 31. Outsourcing
• 32. The FDA
• 33. FDA Inspectors

William J. Mead holds two degrees in chemical engineering from Ohio State, and an MS in Industrial Management from the Stevens Institute of Technology. He is a licensed Professional Engineer. At one point, he served as an Adjunct Professor in the Graduate School of Pace University. He remains active in the American Chemical Society, the American Institute of Chemical Engineers, the Society of Cosmetic Chemists, the American Society for the Advancement of Science, the American Society for Quality, the PDA, the New York Academy of Sciences, and the Chemists’ Club.

He has served as vice president of manufacturing for several well-known corporations involved with consumer products, and thus has had long first-hand experience in GMP compliance, both in the USA and overseas.

“Bill Mead’s primer Dietary Supplement Good Manufacturing Practices – Preparing for Compliance, should be required reading for every quality control department in the supplement industry. The book dissects and digests the FDA’s lengthy regulations and preamble, making the minutiae of a very complicated rulemaking understandable so the requirements can actually be implemented. Bill Mead offers not only “what” the rule requires but “how” to comply, and “why” each topic is critical to pass your next inspection. Conscientious firms will want to read cover to cover before the FDA inspector knocks on the door.”

- Steve Mister, President & CEO (Council for Responsible Nutrition)