Continued Process Verification – A Systematic Approach

Date	Sep 11, 2018
Time	03:00 PM EDT
Cost	$15755.00
Online

The FDA’s Process Validation Guidance calls for “Continued Process Verification” in Stage 3 of the Guidance which focuses on continual assessment of process performance and product quality throughout the life of the product. Combining process control with process improvement creates a system that satisfies the direction of ICH Q8 (R2) and FDA’s guidance for continued process verification, continuous improvement and life cycle management. This presentation describes a disciplined and structured “Quality by Design” approach to achieve this objective.

Areas Covered in the Session :

• FDA Guidance regarding Process Validation and Continued Process Verification
• Building Blocks of QbD – Design Space, Process Control and Assessing Risk
• Process Control Strategy – Stability and Capability Methods
• Process Performance and Product Quality – A Systems Approach
• The Vision for Process Monitoring and Control Building Blocks
• Successful Deployment, Getting Started and Sustaining the Initiative
• Tips and traps – What to watch out for

Who Should Attend:

• Executives and Managers of Pharma and Biotech Companies
• Process and Manufacturing Engineers
• Quality Assurance Departments
• Regulatory Affairs Departments
• Quality Control Lab Personnel
• Quality Engineers
• Research and Development Departments
• Biologists and Microbiologists
• Chemists and Chemical Engineers