GOOD MANUFACTURING PRACTICES IN THE PHARMACEUTICAL, BIOTECHNOLOGY AND MEDICAL DEVICE INDUSTRIES

1. GOOD MANUFACTURING PRACTICES IN THE PHARMACEUTICAL, BIOTECHNOLOGY AND MEDICAL DEVICE INDUSTRIES

3. MODULE 1- THE HISTORY OF THE DEVELOPMENT OF GOOD MANUFACTURING PRACTICES (GMP) • State versus Federal Powers and the Regulation of Commerce

4. Versus

5. MODULE 1-CONTINUED • Separation of Powers

6. MODULE 1-CONTINUED • History of FDA • What the FDA Regulates • Summary of the Mission and Fundamental Activities of the FDA

7. MODULE 2 - THE FDA AND PHARMACEUTICAL DEVELOPMENT • FDA Background • FDA Organization • Process of Drug Development • Notes

8. MODULE 3 – THE FDA AND MEDICAL DEVICES

9. MODULE 3 –CONTINUED • Introduction • Classification of a Medical Device • Regulatory Requirements for Medical Devices

10. MODULE 4 - ESSENTIALS OF GOOD MANUFACTURING PRACTICES • Introduction • Regulations • Risk-Based Approach to FDA Regulation of GMP

11. MODULE 4 - CONTINUED • Further Background on Current Good Manufacturing Practices • CGMP Procedures • FDA Inspection, Warning Letters and Post-Marketing Regulation

12. MODULE 5 - BUILDINGS AND FACILITIES FOR GMP • Design and Construction

13. MODULE 5 - CONTINUED • Plant Materials

14. MODULE 5 - CONTINUED • Ventilation, Air Filtration; Air Heating and Cooling

15. MODULE 5 - CONTINUED • Plumbing • Lighting • Sewage and Refuse • Sanitation • Maintenance

16. MODULE 6 - RECEIVING AND QUARANTINE OPERATIONS • Introduction • General Requirements • Receipt and Storage of Untested Components, Drug Product Containers and Closures • Testing and Approval or Rejection of Components, Drug Product Containers and Closures

17. MODULE 6 - CONTINUED • Use of Approved Components, Drug Product Containers, and Closures

18. MODULE 6 - CONTINUED • Retesting of Approved Components, Drug Product Containers, and Closures • Rejected Components, Drug Product Containers, and Closures • Drug Product Containers and Closures

19. MODULE 7 - HOLDING AND DISTRIBUTION • Introduction • Warehousing Procedures • Distribution Procedures

20. MODULE 8 - QUALITY ASSURANCE AND VALIDATION • FUNDAMENTALS • IMPLEMENTATION OF VALIDATION • HOW VALIDATION GETS DONE • PLANNING THE VALIDATION PROJECT • PROCESS VALIDATION

21. MODULE 9 - AUDITS • Introduction • What is an Audit?

22. MODULE 9 - CONTINUED • What is an Internal Audit? • What is an External Audit? • The Quality Systems Approach • Example of a Quality Audit • Medical Device Regulations • Detecting Potential Problems • The Audit Program

23. THE END THANK YOU!