How to Develop PAT Approach-Regulatory Compliance 2015

Topics

• Regulatory impact of implementing PAT approach in R&D and production
• The fundamental concepts behind the FDA PAT initiative
• Efficient on-line and at-line tools for predicting quality attributes based on process data
• Use of multivariate data analysis (MVDA) and statistical process control
• Tools for root cause determination, trending analysis and visualization
• Design space verification and real time quality assurance

Who should Attend

• Process engineers
• Formulators
• Quality assurance personnel
• Validation specialists
• Anyone involved in risk mitigation and regulatory compliance
• Production managers