Continued Process Verification – A Systematic Approach

MessageThis Webinar is over
Date Sep 11, 2018
Time (1:00 pm to 2:30 pm)
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

 


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