1. Concept and Evolution of Quality Control and Quality Assurance .2. Quality Control Laboratory Responsibilities 3. CPCSEA Guidelines 4. Quality Review and Batch Release Document of Finished Products 5. Annual Product Quality Review and Parametric Release 6. Audits 7. Quality Audits of Manufacturing Processes and Facilities 8. Good Documentation Practices 9. Root Cause Analysis 10. Corrective Action Preventive Action (CAPA) 11. Out of Specifications (OOS) and Out of Trend (OOT) 12. Clinical Studies - ICH GCP (E6) guidelines 13. Post Marketing Surveillance 14. Pharmacovigilance .15. Bioavailability and Bioequivalence Studies 16. Concepts and Management of Contract Manufacturing Guidelines 17. Statistical Tools for Quality Control and Precision 18. Tools of Problem Solving and Continuous Improvement .19. Introduction to Intellectual Property Rights (IPR)20. Introduction to Intellectual Property Rights (IPR)21. Concept of Trademark, Copyright, and Patents 22. Product Registration Guidelines – CDSCO, USFDA 23. Concept of ISO (9001): (2008), (14000), OSHAS Guidelines 24. Quality Strategy for Indian Industry25. Brief Concept of IND, NDA, ANDA, SNDA, and PAT