Pharmaceutical Manufacturing Science and Process Analytical Technology

Quality Revolution in the Manufacturing Sector. Principles of Risk Management in Manufacturing. Origin, Objectives, and Evolution of the Process Analytical Technology Initiative in the U.S. and Europe. Origin, Objectives, and Evolution of the FDA's Initiative on Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach. Pharmaceutical Quality and Metrics. Principles of Quality by Design. Manufacturing Science and Risk Mitigation: Theory and Practice. Technology and Knowledge Transfer from Development to Production. Continuous Improvement and Knowledge Management in Pharmaceutical Manufacturing. Principles of Pharmaceutical Risk Assessment and Mitigation: CMC Review. Principles of Pharmaceutical Risk Assessment and Mitigation: GMP Compliance. Process Development and Optimization: Statistical and Simulation Principles and Tools. Current and Emerging Process Analytical Chemistry Tools and Approaches. Multivariate Statistical Process Control and Chemometrics. Current and Future Directions in Real-Time Control of Pharmaceutical Processes: API. Current and Future Directions in Real-Time Control of Pharmaceutical Processes: Drug Product. Design of Pharmaceutical Equipment to Achieve Real-Time Process Control. Scale-Up in the 4th Dimension. Continuous Manufacturing: Principles and Approaches. Real-Time Data Acquisition and Analysis. Continuous Quality Assurance and Real-Time Release. Validation of Process Control Systems. Technologies and Approaches for Science Based Corrective Actions. Need for an Integrated Systems Approach to Pharmaceutical Quality. International Approaches to Operationalize the Elements of Pharmaceutical GMPs for the 21st Century