Pharmaceutical Operations Management focuses on policy execution, risk management, supply chain management, advance process control, and Six Sigma for the pharmaceutical industry.
Learn how to:
- Focus on quality by design
- Integrate strategy and execution
- Turn chaos into opportunity
- Bridge the gap between technologists and management
- Decrease research and development time and cost
- Reduce time to market
Contents
Process Design
- Economics of Scale
- Scale-Down
- Laboratory-Pilot-Scale Development
- Scale-Down in the Biopharmaceutical Industry
Manufacturability
- Process Design Finalization
- Process Integration
- Process Simplification
- Process Flow Description
- Risk Management
- Modeling-Effectiveness in Handling Variable Capacity Opportunity
- User Requirement Specification
- Execution of the Manufacturing System
- Quality System
Critical Control Strategy
- Critical Process Parameter Measurement
- Data Management
- Control of Critical Process Parameters
- Process Control Case Study C
Knowledge Management
- Learning and Innovation
- Knowledge Management
- Knowledge Elicitation
- Turning Intellectual Property into Action
- Industrial Case Study D
Fundamental Strategies for Variability Reduction
- Control Charting for Variables
- Special Cause Identification
- Understanding Control Charting Using Case Study E
- Advanced Charting Methods
- Capability Analysis of a Stable Process
- EPC and SPC
- Root Cause Analysis
- System Decay
Emerging Monitoring and Control Strategies
- Advanced Process Control
- Multivariate Statistical Process Control
- Artificial Neural Networks
- Knowledge-Based Systems
Productivity Improvement Methodologies
- Six Sigma
- Six Sigma Improvement Process
- Lean Six Sigma
- Six Sigma Toolset
- Case Study H
- Design for Six Sigma
Productivity Improvement Philosophy
- Transformational Leadership
- Siloless Synergy
- Logistical Aspect of Productivity Improvement
- Productivity Target
- Productivity Improvement Case Study
Index