Biopharmaceuticals and Risk Management: What do ICH Q8 and Q9 mean?

In this Biopharmaceuticals training learn how can this guidance be applied given the rapid pace of development, the difficulty of defining the process and the product early in development, and the ever-changing regulatory environment. New draft guidance from the ICH indicates that process development should include risk assessment, definition of ’design space’, and suitable designed experiments to define a safe operating range.

New draft guidance from the ICH indicates that process development should include risk assessment, definition of ’design space’, and suitable designed experiments to define a safe operating range. How to define your own strategy on process development given the rapid pace of development, the difficulty of defining the process and the product early in development, and the ever-changing regulatory environment.How can this guidance be applied given the rapid pace of development, the difficulty of defining the process and the product early in development, and the ever-changing regulatory environment? This talk discusses approaches to defining your own strategy.

Areas Covered in the seminar:

• Defining risks for a biopharmaceutical

'Design space': What is it?

• Process development as a risk reduction strategy
• Process validation to document process performance
• Reducing risks in the change control program
• Reducing compliance risk: handling exceptions and complaints
• How safe is safe enough-at clinical and commercial stages?

Who Will Benefit

• Development scientists
• QC and analytical methods development scientists and managers
• QA managers and personnel
• Manufacturing
• Regulatory affairs