Understanding and Implementing a Quality by Design (QbD) Program

Overview:

Substantial business benefits are emerging from industry when Quality by Design (QbD) principles are used for new and existing drug products yielding reduced operating costs, enabling significantly more efficient manufacturing processes and better positioning companies to meet increasing regulatory expectations.

For example, the completion of ICH Guidelines, Q8 (R2): Pharmaceutical Development, Q9: Quality Risk Management and Q10: Pharmaceutical Quality System and the recent USFDA and Health Canada guidance’s on Process Validation contain recommendations for building and capturing process knowledge and understanding and establishing a strategy for process control during process design.

Why you should Attend:

Prepare participants to better understand the principles behind using QbD to develop a pharmaceutical product:

• Understand what is meant by Quality be Design
• Understand the benefits from applying a QbD approach
• Provide key steps to implement a QbD program
• Understand what the important tools used to implement a QbD approach

Areas Covered in the Session:

QbD principles discussed in this webinar include

• Quality Target Product Profile (QTPP)
• Risk Assessment
• Process Analytical Technology (PAT)
• Target Operational Profile
• Control Strategy

Who Will Benefit:

• Manufacturing Engineer, Quality Engineer, validation specialist/manager, Quality Manager with intermediate level experience in manufacturing, engineering, validation, quality control and assurance 
• Technology transfer Lead /Manager, MSAT professionals, and those that are new to Quality by Design principles