Planning Organizing and Design of Research in Pharmaceutical industry
10. L16. RESEARCH METHODOLOGY
Study Design and optimization techniques
11. L17. PROFESSIONAL AND BUSINESS ETHICS
Introduction Importance Design of policy
12. L18. REVIEW SESSION
. QUALITY ASSURANCE AND REGULATORY AFFAIRS
1. L1-2. DRUG DISCOVERY AND DEVELOPMENT
Preclinical Studies Investigational New Drug (IND) Application 2. L3-4. CLINICAL TRIALS Stages of clinical Trials New Drug Application (NDA) 3. L5. OVERVIEW OF QUALITY CONTROL AND VALIDATION PROCESS IN A PHARMACEUTICAL INDUSTRY. Quality Variation Quality Variation Control Quality Control 4. L6. COST OF QUALITY Quality Control Data Quality Process Validation in Pharmaceutical Industry 5. L7. QUALITY IMPROVEMENT TECHNIQUES Quality By Design QbD Quality by Design Tools 6. L8-12. STATISTICAL QUALITY CONTROL (SQC) Variation Standard Deviation () Normal Curve Z value Control Chart R-Chart Mean chart P-Chart R-Bar Chart C-Chart State of Control Out-of-Control Patterns 7. L13. TOTAL QUALITY MANAGEMENT The Dimensions of Quality TQM Philosophy Demings 14 Points for Management TOOLS TO IMPLEMENT TQM PARETO ANALYSIS HISTOGRAMS 8. L14-15. GOOD MANUFACTURING PRACTICES 9. L16. NATIONAL GOOD LABORATORY PRACTICE (GLP) COMPLIANCE MONITORING AUTHORITY (NGCMA) International Organization for Standardization (ISO) ISO 9000