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PHARMACEUTICAL ADMINISTRATION AND MANAGEMENT

1. L1. INTRODUCTION
Drug Discovery
Product Development
Pharmaceutical Administration and Management

2. L2-4. PRODUCTION MANAGEMENT


Introduction of management
Production management

3. L5-6. PRODUCTION MANAGEMENT


Planning and control

4. L7. INVENTORY MANAGEMENT


5. L8. BASIC FINANCIAL MANAGEMENT
6. L9. REVIEW SESSION
7. L10-11. MARKETING MANAGEMENT
Designing Marketing Strategy
Life Cycle Management
Marketing Mix

8. L12-13. MARKET RESEARCH


Objectives
Strategies
Importance
Sales Forecasting

9. L14-15. RESEARCH METHODOLOGY


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

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